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.

Out of work? Maybe you’d like a job at that most trustworthy and hallowed of institutions, the FDA. Qualifications are rather stringent, so you may be disqualified. Basically, they require you to be dishonest, be adept at spreading misinformation, be good at kissing ass, firmly believe in censorship (that is, censoring anything that doesn’t benefit the industry you are supposed to be regulating), and be good at threatening whistleblowers. Sound like you’re kind of place? Go for it.

In a hilarious article (maybe it’s so funny because it’s so true), News Target satires new employment postings at the FDA. Some highlights:

Propaganda Officer: Help the FDA create and spread information that discredits products, companies and ideas that threaten FDA control. No scientific background necessary.

Science Censor: Bury scientific findings that harm the prestige and credibility of the FDA.

Chief Oppression Officer: Conduct armed raids on places where dangerous criminals are teaching patients about nutrition.

Kickback Coordinator: Keep tabs on FDA managers’ investments in pharmaceutical companies. Criminal background preferred, mob ties are a plus.

Morale Officer: Keep FDA employees in line to boost morale and work efficiency.

Public Safety Program Director: Not really a full-time job. In fact, you don’t even need to show up.

It is refreshing to know that there are reputable people working at the FDA. The Vioxx whistleblower was one. Susan Wood, director of FDA’s Office of Women’s Health, is another. Unfortunately, she has resigned over the FDA’s decision to be indecisive. Yes, it’s Plan B again, better known as emergency contraception or the morning after pill. Wood just got so fed up that she quit.

CNN published the email that she sent to her colleagues at the FDA, and which was released by contraception advocates.

“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” wrote Wood, who also was assistant commissioner for women’s health. “The recent decision announced by the Commissioner about emergency contraception, which continues to limit women’s access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women’s health.”

Not only has the FDA caved into political pressure from our merry band of neocons, but they have proven themselves to be liars. Case in point: Lester Crawford, now the pathetic commissioner, finally broke the stalemate in the Senate regarding his confirmation only after promising members of Congress to make a final decision by September 1. And guess what? No decision. Or I take that back–the fool made the grand decision not to make a decision. In other words, he lied in order to be confirmed. Nice going, Lester. It’s comforting to have guys like you playing around with our food and drugs.

You just gotta love ‘em. Now, after over 2 years of debating (28 months to be exact) and receiving the nearly unanimous blessing of their advisory committee, the FDA has reached a decision on whether or not to make the morning after pill available over the counter. The verdict? Okay, get the ammonia capsules ready.

Our hallowed Food and Drug Administration hs announced that they have “indefinitely postponed its ruling” on whether women should be allowed to buy the “morning-after pill” Plan B without a prescription–despite assurances that it would act by Sept. 1.

The decision to embark instead on a new regulation-writing process was denounced by women’s health advocates and some lawmakers as a stalling tactic. A formal rulemaking generally takes years to finish.

“What we’re saying today is that there are unique regulatory issues here that need to be addressed before we can make a decision on this application,” he said, adding he could not estimate how long that might take.

It is really a shame that the FDA has transformed into such a sad joke, and that they are caving in to pressure from fanatical neocons–who quite obviously, prefer to see fetuses aborted rather than pregnancy prevented. But why should anyone be surprised? A few days ago I posted on how a biotech insider, one who advised investors, has landed a spot as a deputy commissioner. And now today, the FDA just can’t bring itself to to the right thing, the job that it was created for, and confirm that the morning after pill be made available over the counter.

The FDA, throughout its history, has always maintained an ultra-cozy relationship with the industries that it is supposed to be regulating. But now, it seems to be completely forgetting science, and is wimping out under political pressure.

Nice going, FDA. I’m so proud that you are looking after the health and welfare of the American people. It just makes me feel so safe!!!

Now, let me and puke.

Read the entire article on the Chicago Tribune.

It is amazing that no paper, other than the Seattle Times, happened to take the initiative and point out Scott Gottlieb’s ties to the biotech industry. I have spent a little time searching the web, and nothing at all comes up. There may be other newspapers who did write on it, of course, but what I can say is that there is a considerable dearth of good reporting. Even a Reuter’s story just mentions Gottlieb as a “former AEI scholar.” Was the media just too lazy to go beyond the press release from the FDA?

Scott Gottlieb, MD, a former FDA and Centers for Medicare and Medicaid Services senior official, is returning as FDA’s new Deputy Commissioner for Medical and Scientific Affairs. In this position, Dr. Gottlieb will coordinate medical and scientific affairs for the Office of the Commissioner serving as senior policy advisor to the Commissioner in these areas. Dr. Gottlieb is a practicing physician who most recently worked as a Resident Fellow at the American Enterprise Institute (AEI), a prominent Washington, DC-based think tank and also spent time as an American medical correspondent for the British Medical Journal.

That is from the official FDA press release of July 29, 2005, annoucing new appointments. It took the Seattle Times almost a month to report that this new appointee has a questionable background (for someone who is supposed to be regulating the industry) but at least they ran the story. In fact, it was on the front page, to their credit. So where is everyone else? And why did the FDA’s official release conveniently omit Scotty’s career in biotech investing? I mean, if there’s no conflict of interest, then why not mention it? Surely it’s nothing to be ashamed of.

If you think the FDA hasn’t sunk to its lowest level yet, think again. With all of the heightened concern about conflict of interest, “experts” being paid to parrot corporate rhetoric rather than real science, and unsafe drugs slipping past the FDA’s pretense at regulation (while they stall and kick the dust around on emergency contraception), our hallowed FDA has hired Dr. Scott Gottlieb as a dputy commissioner.

Perhaps you aren’t gagging yet because you don’t know who Dr. Gottlieb is. Well, I’ll tell you. From the Seattle Times:

Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May–”Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38 percent. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, ‘Three Biotech Stocks To Buy Now.’”

In his new job, Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry. Isn’t that a cozy relationship? Is this the only person that the FDA could have found for the job?

Gottlieb says that he “cut” his ties and doesn’t think there’s a conflict of interest. Isn’t that sweet. What a guy. And here’s some of the new and great ideas that Scott brings to the FDA. comes to the FDA with an agenda. He wants to speed up drug approvals, which can be a good or bad thing, depending on what you mean by speeding it up. But in Scotty’s case, I think his concern is more for the investor and the drug company, rather than getting an essential drug safely and quickly to the consumer.

Here’s the clinicher though. Scotty also thinks that “the FDA sends out too many “shotgun warnings” on any particular drug’s emerging side effects, which he said may cause patients to overreact.” My, my, imagine that. Imagine how many people might still be alive if more attention had been paid to the early warnings about Vioxx.

When the FDA announced Gottlieb’s hiring last month, it noted that he had been a practicing physician, a correspondent for the British Medical Journal, and a scholar at the American Enterprise Institute (a conservative think tank)But if there’s no question about conflict of interest, then why did they conveniently not mention his career as editor of the two popular biotech investment newsletters or his work with Wall Street firms.

This whole thing reeks, as does Gottlieb now trying to portray himself as a squeaky clean physician without any industry ties. Just when you think that the FDA can’t sink any lower, and make even a bigger fool of itself.

The FDA received more than 422,500 reports of drug side effects last year, which is a record high, according to an AP report.

The final figures aren’t out, but the preliminary ones report that these numbers top the 2003 figures of 370,887. But wouldn’t you know, the FDA immediately jumps to the conclusion that it can’t be the drugs that are at fault.

Agency officials attribute the rise to increased use of prescription drugs rather than an increase in risk from the drugs.

Uh, so the fact that maybe 100,000 people died from using Vioxx is just because of an overall increase in the use of prescription drugs? That the drugs that we are putting on the market have nothing to do with this?

That reminds me of some of the reaons given for the rise in breast cancer rates. Not that the cancer can possibly have anything to do with heavy pesticide usage, environmental pollutants, carcinogens in food, overall diet, etc., but that the rising rates are “due to more women getting mammograms.” So in other words, if you believe that, rates of breast cancer were exactly the same in 1900 as they are now, only women just didn’t know they were dying of it.

I need a drink.

The controversy rages. Vaccines can lead to autism, vaccines don’t lead to autism, vaccines can lead to autism, vaccines don’t lead to autism. It can really confuse you because both sides wave papers and reports, the quoted “experts” all have credentials, yet you wonder–how can their views be so far apart?

The official government agencies have all dismissed any claims that there is a connection between the two. The measles-mumps-rubella vaccine, and vaccines which contain thimerosal (a mercury based preservative) have been declared safe. Done and done, and they don’t want to hear anymore about it. But then, as it has come to light, many of the government scientists work as “consultants” for pharm companies, own ample stock, and have a great deal to gain or lose, depending on which way the wind is blowing. This is not to say that anyone who believes that the vaccines are safe is biased (ie, a financially induced response and viewpoint), but it is a fact to take into consideration. Who and where is the data coming from?

If you’re not a parent, these debates are probably of little interest. But for those with young children, who intend on having a family, and others with a vested interest in the welfare of children—the conflicting data is mind-numbing.

Now, as Project Censored has demonstrated, many of the most important stories never make it in the mainstream press. Some got a tiny mention, while others are ignored completely or watered down. The public, it does seem, would rather see headlines about Laci Peterson (sad case, but then, no sadder than any other murder), day in and day out, and wait on baited breath for the courtroom verdict–then read about, say, how the main companies that were awarded billions of dollars worth of contracts in Iraq have paid more than $300 million in fines since 2000, to resolve allegations of fraud, bid rigging, delivery of faulty military equipment, and environmental damage.

Anyway, I came across this story which caught my eye about thimersol and vaccines. It is from Independent Media TV, which describes itself in the following manner:

Independent Media is designed to be an independent media outlet for views and artistic expression which are currently not being represented by our corporate media. Independent Media has various areas of focus. The Under Reported and Environmental areas are designed to bring to light information, and knowledge that is otherwise not reaching the general public. The Philosophical, and Independent Artist areas are designed to be a forum of expression for artists of Music, Movies, Writing, Art, Philosophy, and Spirituality. This is needed as the corporate media monopoly controls the majority of what we see and hear.

So no influence from government or business. Okay, and this is what they had to say about some of the factors influencing an objective review of vaccine safety.

In 1999, the Committee on Government Reform initiated an investigation into Federal vaccine policy. Their 8 month investigation focused on conflicts of interest on the part of Federal policy-makers. Committee staff conducted an extensive review of financial disclosure forms and interviewed key officials from the Department of Health and Human Services, including the FDA and CDC.

The staff report that was issued, focused on two advisory committees utilized by Federal regulators to provide expert advice on vaccine policy: (1) The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC); and (2) The CDC’s Advisory Committee on Immunizations Practices (ACIP).

The VRBPAC advises the FDA on the licensing of new vaccines, while the ACIP advises the CDC on guidelines to be issued to doctors and the states for the proper use of vaccines.

The Government Reform Committee determined that conflict of interest rules employed by the FDA and the CDC were weak, enforcement was lax, and advisory committee members with substantial ties to drug companies have been given waivers to participate in committee proceedings. The specific problems identified in the staff report included:

‘ The CDC routinely grants waivers from conflict of interest rules to every member of its advisory committee.

‘ CDC Advisory Committee members who are not allowed to vote on certain recommendations due to financial conflicts of interest are allowed to participate in committee deliberations and advocate specific positions.

‘ The Chairman of the CDC’s advisory committee until recently owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.

‘ Members of the CDC’s advisory committee often fill out incomplete financial disclosure statements, and are not required to provide the missing information by CDC ethics officials.

‘ Four out of eight CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

‘ 3 out of 5 FDA advisory committee members who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

A four-month investigation by United Press International, determined that members of the CDC’s Vaccine Advisory Committee received financial benefits from vaccine makers. Relationships included: sharing a vaccine patent; owning stock in a vaccine company; payments for research; getting money to monitor manufacturer vaccine tests; and funding academic departments. UPI also found that under a 1980 law, the CDC had 28 licensing agreements with companies, and one university, for vaccines or vaccine-related products. In addition, the CDC had eight on-going projects to collaborate on new vaccines.

A prime example of the conflicts of interest is Dr Paul Offit. He held a patent on a rotavirus vaccine and received a grant of $350,000 from Merck to develop the vaccine. He was also paid by the pharmaceutical industry to travel around the country and teach doctors that vaccines are safe. Offit was a member of the CDC’s advisory committee and voted on three rotavirus issues, including the recommendation of adding the rotavirus vaccine to the Vaccines for Children’s program.

According to some accounts, the cost of developing a new vaccine can cost half a billion dollars, which explains why a tight relationship with the CDC is priceless. An approval by the regulatory agency guarantees a market for a new vaccine, and under a 1986 law, CDC approval limits a drugmaker’s liability for side effects. Adverse Effects Known For Years

Now is that enough to make you nervous? Are our vaccines really as safe as they should be, or is the main goal profit? Can we trust our government agencies when primary players have a vested interest in bringing a product to market, safe or not?

Thimerosal

Mercury is a deadly metal, and it is not something that you want in our body. Of course, dental fillings used to be filled with mercury, and thanks to widescale pollution, many fish are stuffed full of the stuff. But should it be in a vaccine, and especially, a vaccine given to a very small infant?

Vaccine manufacturers have declared thimerosal perfectly safe for infants, and the levels in vaccines are “minute” and within safe limits.

A recently discovered internal memo from the drug company, Merck, substantiates what many parents of autistic children have long suspected. The drug companies, and later the CDC and FDA, knew mercury caused autism, and decided profits were more important than protecting a generation of children against brain damage.

The LA Times recently reported that Merck knew the overuse of mercury in their vaccines posed a dangerous health threat to children. The Times cited a 1991 memo issued by Merck that said that 6-month-old children who received their shots on schedule would get a mercury dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish.

A copy of the memo was provided to attorneys for Vera Easter, a Texas woman who blames thimerosal for the condition of her 7-year-old son, Jordan, who is autistic and mentally retarded. That lawsuit is pending in US District Court for the Eastern District of Texas. The defendants include Merck and its rival vaccine makers, GlaxoSmithKline, Aventis Pasteur Inc. and Wyeth; and thimerosal developer Eli Lilly & Co.

The disclosure of Merck’s findings in 1991, could have prevented millions of children from the damage caused by the poisonous vaccines. According to the House Committee on Government Reform in April 2003, “Because the FDA chose not to recall thimerosal-containing vaccines in 1999, in addition to all of those already injured, 8,000 children a day continued to be placed at risk for overdose for at least an additional two years,” its report concluded. Think how many children that adds up to if we go back to1991.

Nice to know, huh, that our govenment watchdogs are looking out for public health and the safety of children. This type of disclosure is quite damaging to the industry, and now the Bush squad has moved to protect vaccine manufacturers from any type of liability. I posted about the Senate bill which pretends to be helping veterans and soldiers, but comes as a package deal.

If these cover-ups are indeed true (and I have a sneaking suspicion that they might be), then what about these poor children? They have been irreversibly poisoned, their lives destroyed, and no one wants to take responsibility for it.

On 14 February, President George W. Bush formally nominated the acting commissioner of the FDA, Lester Crawford, for the permanent job.

“Dr. Lester Crawford is an outstanding choice for Commissioner of the Food and Drug Administration,” said newly-appointed Secretary of Health and Human Services Mike Leavitt in a statement. “With Dr. Crawford’s leadership, FDA will provide the world’s safest drugs and empower citizens with the tools they need to make to make informed choices about their health.”

And so far, Dr. Crawford has done just a stellar job at that (please note, my voice is dripping with sarcasm). Is Mike Leavitt blind or deaf or what?

Under Crawford’s short time as acting commissioner, the FDA has been enmeshed in some of its worst scandals of all time. First, there came Vioxx, when whistle-blower David Graham announced that the Center for Drug Evaluation and Research (CDER) had tried to prevent him from disseminating information about the danger of the drug. The allegations that the FDA suppressed results about the safety of COX-2 inhibitors all occured under Crawford’s leadership. And then there was the refusal to allow Plan B to come on the market over the counter. The FDA has been accused, in that case, of bowing to political pressure rather than making decisions based on science and public health.

It is also interesting to note that Crawfor was originally considered for the job and then rejected in 2001.

Dr. Crawford’s leadership has come under fierce criticism. When British health authorities condemned more than 40 million doses of flu vaccine from a plant in England and left the United States critically short of the medicine, Dr. Crawford said he was shocked by the news, a comment that led some critics to ask why his agency was surprised by problems that its inspectors had identified.

The agency was slow to acknowledge that antidepressants can cause depressed children and teenagers to be suicidal, even though one of its top safety officials was the first to confirm the link. And when Merck withdrew Vioxx in September because of data showing that it hurt the heart, the agency was criticized for failing to warn more strongly about the drug’s dangers years earlier.

So certainly, Lester Crawford has not led the FDA during its finest hour. In fact, the agency seems to have gone to complete hell since he stepped in. His nomination has gotten mixed support from Dems and Repubs, and he has been widely condemned by consumer advocacy organizations and womens’ groups. You have to wonder why the permanent position would be offered to someone who so clearly screwed up during his temporary appointment. He’s had his chance, he blew it big time. Give him his pink slip and send him packing, for heaven’s sake.

What is needed is someone fresh, an academic or public health official without ties to the drug industry, and a person who can stand up to political pressure. But I kinda doubt that is going to happen.

So we heard, Vioxx is deadly. Is it off the market? Well, yes, but maybe not for the long. Even though this drug is responsible for heart attacks and stroke in the range of 88,000 to 40,000 people, the FDA has not banned it.

You read correctly. Vioxx has been “temporarily” removed from the marketplace, but its manufacturer, is quite anxious to see it returned. And so, the pharm industry’s lapdog, aka the FDA, is barking to their tune.

The popular painkillers Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them, advisers to the Food and Drug Administration said Friday.

The panel strongly favored keeping Celebrex on the market, split over Bextra and favored Vioxx — which is currently not on sale — by a vote of just 17-16.

Of course the FDA is not obligated to follow the advice of their panel, which they ceremoniously ignored when it unanimously voted to make the morning after pill available over the counter. But why do I suspect that Vioxx will be back on the market, and this whole affair will be much ado about nothing?

Merck, who manufactures Vioxx, had their stock shoot up by 12% as soon as the announcement was made. Pfizer shares rose as well. Let’s face it, taking drugs off the market is bad business.

What is interesting is that if this had been a vitamin, an herb, or something related to the health food and alternative medicine industry, you better believe that the FDA would have spun its wheels and pulled that sucker off the shelves faster than a speeding bullit. A prime example is the case of tryptophan, a naturally occurring amino acid.

During the 1980’s, tryptophan was widely available as a supplement in health food stores and other major retail outlets such as supermarkets and drug stores. Individuals used it for sleeping difficulties, premenstrual syndrome, stress, depression, etc. In 1990 a single batch, from a single company, used an untested genetic engineering procedure which began to produce highly toxic contaminants. It caused a rare disease called Eosinophilia-Myalgia Syndrome (EMS), which is characterized by severe muscle pain and a dramatic increase in the number of eosinophils, a type of white blood cell. About 1500 cases of EMS were reported, with 27 deaths.

Tryptophan was yanked from the market, and has never been allowed back, except by doctor’s prescription. It has been 15 years since the incident, tryptophan caused no problems before this, and has caused none since (it is available elsewhere and used in hospitals). But the FDA says no can do, tryptophan is gone for good. Now, strangely enough, right about this time Prozac came on the market. What a surprise, that the FDA was trying to keep people from using a very effective, very inexpensive substance, which had virtually no side effects. The SSRI anti-depressants were slated to make a fortune, and the FDA made sure to keep tryptophan out of the way.

Of course, this is a conspiracy theory, but is there any other explanation? Why they continue to prohibit the sale of tryptophan, but yet allow items like trans fats, which kill maybe 100,000 people a year, to flourish? And have been diddling around with the Cox-2 inhibitors, which have clearly been shown to be very dangerous? Isn’t the FDA supposed to be protecting consumer health, and not trying to raise stock prices at Merck?

The advisers did suggest putting restrictions on the drugs, such as the dreaded “black box” warning (aka the kiss of death for a drug), and including more patient information and perhaps even resistricting who can even get them. They also suggested–horror-of -horrors–banning direct-to-consumer advertising for the products. No more “celebrate with Celebrex.”

It should be interesting to see the next move. Vioxx should be banned, no question. It has already proven itself, and how do you really restrict which patients get what drug. If a patient wants a drug and a doctor prescribes it, they will get it, dangerous or not. The other Cox-2 inhibitors may be open to more debate, but definitely, we need to see what’s going on with them, and get rid of the advertising. As for now, they should not be prescribed to any patient who can do well with a different drug.

The FDA still has not granted over-the-counter status for Plan B, better known as the “morning after pill.” I’m too busy this morning to get into another one of my “slash ‘n burn” the FDA moods, but this is getting ridiculous. What are they waiting for, approval from George Bush and the far far far neocon pseudo-Christian right wingers?

Anyway, here’s a press release from Congresswoman Carolyn Maloney (NY-14), who has been a staunch advocate for getting the FDA to behave like a federal agency enshrined with protecting the health of the public, and not a political mouthpiece.

FDA Violating Law by Stalling on Morning-After Pill, Says “Sound Science” Amendment Author

WASHINGTON, DC – The Food and Drug Administration (FDA) is violating the law by delaying its decision on granting over-the-counter (OTC) status for the morning-after pill, says the law’s author. A rider attached to the FY05 Agriculture Appropriations bill prohibits the FDA from actions that run counter to its obligation to make decisions based on sound science, not political or ideological considerations (http://www.house.gov/maloney/issues/choice/SoundScience.pdf – see Sec. 774). However, by extending its timeline and continuing deliberation on whether to grant OTC for the Plan B ® contraceptive, the FDA is ignoring the intent of Congress and the overwhelming recommendation of its own scientific panel.

“The FDA’s stall tactics are in clear violation of the law,” said Maloney. “Last year, they said they objected because they were worried about girls 16 and under. That issue has been taken care of with Barr’s new application, so they’re looking for a new excuse to mask their ideological opposition. They’re ignoring the scientific evidence, and that’s harming women’s health.”

Reps. Carolyn Maloney (NY-14) and Henry Waxman (CA-30) successfully offered the “FDA Sound-Science Amendment,” which was introduced after the FDA denied OTC status for Plan B ®, despite the 23-4 recommendation of its expert panel to the contrary. Barr Pharmacies, the maker of Plan B ®, has since reapplied for OTC status only for women over 16, but the FDA announced late last week that it is delaying its decision on that application

By now I’m sure that the FDA would prefer that it never heard that nasty work “Vioxx.” But they were negligent in approving the drug in the first place, and for not following it more carefully during its initial years on the market. Sorry, but that’s how it goes. If the FDA can’t be held responsible, then who is?

“The FDA has become a little bit too beholden to the drug companies and is either unwilling, afraid or unable to get them to do the safety studies that need to get done once there’s a signal that there may be a problem,” said Dr. Jerry Avorn of Harvard, who co-authored an editorial in Tuesday’s issue of Archives of Internal Medicine.

The Chicago Tribune reports that a study just published in the British medical journal Lancet, suggests that Vioxx may be connected to tens of thousands of deaths. Adding further fuel, an editorial appeared a day later in the American journal Archives of Internal Medicine, calling for a major overhaul of the way the FDA approves and monitors new drugs.

It is interesting to note that The Lancet study was done by David Graham, associate director for science in the FDA’s Office of Drug Safety, the same man who said his supervisors tried to suppress his findings in back in November, right before he was scheduled to appear before a congressional committee and spill out the truth on Vioxx.

“The FDA had responsibility for regulating this drug, and they didn’t do what they should have,” Graham said Monday in a telephone interview. “I believe the FDA … views industry as its client and not the public, and that what happened with Vioxx is an example of that.”

With the exception of a labeling change in 2002 that referred to potential heart risk, Graham said, “the FDA allowed Vioxx to be marketed extensively without effectively dealing with the risk or informing consumers.”

Vioxx was the most heavily advertised drug in the year 2000, with the manufacturer, Merck, spending $161 million to peddle it to the public. A second study, also from the Archives of Internal Medicine, found that mass marketing often led doctors to switch patients over from cheaper (and safer) drugs, when it wasn’t necessary at all. Plain old over the counter Aleve and Advil work just as well as Vioxx, except that they can increase the risk of gastrointestinal bleeding. But not everyone needs to worry about that and in fact, the study showed that in 2001 7.6 million patients, or 40% of those at a very low risk of bleeding, were prescribed Vioxx.

Should the FDA withdraw the other Cox-2 inhibitors? Are they as dangerous? Some experts and consumer groups say yes, act now, before we have another “revelation” like the one with Vioxx. The consumer watchdog group Public Citizen has already filed a petition to the FDA to immediately remove Celebrex and Bextra off the market.

And so the sad story continues. Needless deaths caused by, in many cases, a drug that they didn’t need. How’s that for medical progress?

This is a press release that I received this am, from the office of New York Congresswoman Carolyn Maloney. It appears that the FDA is doing more than just violating its reason for being; by refusing to act on Plan B, they are in violation of the law. So perhaps criminal prosecution is in order?

FDA Violating Law by Stalling on Morning-After Pill, Says “Sound Science” Amendment Author

FDA still has not granted over-the-counter status for Plan B ®

WASHINGTON, DC – The Food and Drug Administration (FDA) is violating the law by delaying its decision on granting over-the-counter (OTC) status for the morning-after pill, says the law’s author. A rider attached to the FY05 Agriculture Appropriations bill prohibits the FDA from actions that run counter to its obligation to make decisions based on sound science, not political or ideological considerations (see section 774). However, by extending its timeline and continuing deliberation on whether to grant OTC for the Plan B ® contraceptive, the FDA is ignoring the intent of Congress and the overwhelming recommendation of its own scientific panel.

“The FDA’s stall tactics are in clear violation of the law,” said Maloney. “Last year, they said they objected because they were worried about girls 16 and under. That issue has been taken care of with Barr’s new application, so they’re looking for a new excuse to mask their ideological opposition. They’re ignoring the scientific evidence, and that’s harming women’s health.”

Reps. Carolyn Maloney (NY-14) and Henry Waxman (CA-30) successfully offered the “FDA Sound-Science Amendment,” which was introduced after the FDA denied OTC status for Plan B ®, despite the 23-4 recommendation of its expert panel to the contrary. Barr Pharmacies, the maker of Plan B ®, has since reapplied for OTC status only for women over 16, but the FDA announced late last week that it is delaying its decision on that application.

Great news for Monday morning! Yesterday I reported on the negligence of the FDA to act in accordance of its mission and its purpose for being, as they are delaying approval for Plan B to be sold over the counter. The Center for Reproductive Rights, a legal advocacy group, has sued the FDA in U.S. District Court for the Eastern District of New York, charging the agency failed to follow proper procedures in its reviews of Plan B.

“The FDA is ignoring the medical and scientific facts. Emergency contraception meets all the criteria for over-the-counter availability for women of all ages,” said Simon Heller, a lawyer for the group.

Just to reiterate, in May 2004, the FDA’s own advisory panel voted 23-4 in favor of approving the over the counter sale of Plan B. But the FDA has proved that it is even more sleazy than ever believed, by caving into demands from the far right religious zealots who claim that this move will increase promiscuity. And of course, needless to say, over 40 documented scientific studies disprove that myth, including a new one which appeared this month in the Journal of the American Medical Association.

I hope more organizations follow and sue them for crimes against humanity.

I know, I know, the FDA is supposed to be our watchdog when it comes to Food, Drugs and herbal tea. But they seem to be completely inept at making sure drugs released onto the public are safe and effective; they ignore warnings because they don’t want to hurt anyone’s feelings (dead consumers don’t count); and now they have completely surrendered any semblance of being a professional and non-biased agency devoted to public health.

The Sad Sad Story of Plan B

Plan B. Better known as the morning after pill. In one of the more disturbing moves on the part of the FDA, Last May, they overruled its top scientific advisers, who overwhelmingly recommended letting the pill be sold over the counter. While not bound to the vote of their advisory board, they almost always follow its recommendation, especially when it is so unanimous.

But the FDA said that safety wasn’t the issue. No, they just needed more information about how young teens might use the pill. Now what does that mean? We have studies coming out of the yin-yang, 15,000 pages of clinical data from more than 40 studies, which have concluded that the morning after pill does not increase sexual activity among teens. What is does do is prevent pregnancy from occurring, if taken within 72 hours of unprotected.

You would think that anyone who believes that abortion is murder would wholeheartedly support getting this little pill on the open market as soon as possible. Make it as easily available as possible. But alas, it seems that we don’t live in a sane society. Many of the critics refuse to acknowledge that teens are having sex, they’re not going to be frightened into celibacy, and accidents are going to happen. It’s a fact of life, and has been for thousands of years, even if some prefer to believe that unmarried people, teens included, kept their zippers up and legs crossed until that frightful moment of history–the Summer of Love, 1968.

Anyway, back to the FDA on this. They were supposed to be reviewing the data that was resubmitted by the manufacturer, for allowing over the counter sales to girls 16 and over. The decision was supposed to have been made this past Friday.

But what do you think happened? The FDA has “delayed” their decision. Their reasoning? None, only that they would complete the review “in the near future,” according to a statement from Barr, the manufacturer. Now, what on earth do they need to review? Their initial refusal was based on the fact that they didn’t have the proper data on “young girls.” So now the “young girls” clause has been eliminated?

What the hell are they waiting for? To see how many teens will get pregnant in the interim? To count the number of women of all ages who will have to race around town, trying to find a doctor’s office open on the weekend, so they can get the hallowed prescription?

Plan B prevents 89% of pregnancies if taken within 72 hours of unprotected intercourse. It does not cause abortions and is in no way related to the RU486. What is happening is that the FDA has abandoned science, public health and welfare, and plain old common sense and instead, is yielding to political pressure and religious fervor.

From USA Today:

The scientific support for expanding access to emergency contraception is solid. The FDA’s job, by law, is to judge the safety and efficacy of drugs, not the morality of people who use them. If scientific evidence were the only guideline, Plan B would have been available without a prescription long ago. If it continues yielding to political pressure and religious fervor, the FDA abdicates its responsibility and assures millions of unnecessary pregnancies and abortions.

Personally, I think they’re being too nice about it. The FDA should be held accountable for every pregnancy and abortion that occurs as a result of a woman not being to obtain Plan B. Better yet, all of the political drones making these devastating decisions should be stripped of their jobs, their pensions, and face prosecution for endangering the public.

The FDA as it now exists is a total disgrace. An inept, corrupt, and thoroughly politicized organization that has lost complete sight of its mission and responsibilities.

The FDA is at it again, providing for the financial health of the biotech industry and ignoring what is the best policy for the general public. This story is actually over a month old, and the link to it in the Washington Post no longer works. Yes, I shelved it away and forgot about it, but it really shouldn’t be ignored.

What we have are new guidelines from our esteemed Food and Drug Administration, that will encourage companies to submit voluntary safety evaluations of bioengineered food crops that sometimes drift and cross-pollinate with plants in nearby fields. Encourage them? That’s like saying that the police department should encourage bank robbers to put down their weapons, or that you should encourage your child not to put his little fingers on the hot stove.

Of course, the biotech industry was bending over backwards and doing sommersaults, and bouncing up and down with glee because this inaction by the FDA means that they have to do exactly nothing. They have to change nothing. And environmental and food-safety advocates are furious, calling it a “poor substitute for the rigorous testing they have sought before the planting of scientifically engineered crops that could enter the nation’s food supply.” And how right they are.

You really have to wonder about the FDA. Just when I think I’ve heard it all, they always have a new trick up their sleeve. Now in case you think I’m being too hard on the FDA, just look at this example. The FDA requires that your Snickers bar contain nutritional information. Like how much protein and Vitamin C and calcium, and so, the bar contains.

Does anyone buy a Snickers bar for its nutritional content? Does anyone care? Does it matter whether or not we know that the Snickers bar contains 0% Vitamin A?

Of course not. People eat candy bars because they want something sweet and gooey, and not because they’re looking for a burst of solid nutrition. If you want Vitamin C, you’ll eat an orange, and not scan the labels of candy bars to see which one is going to give you the highest content of vitamin C. Those labels never cease to amaze me. Excess cost, waste of paper, and for no apparent reason. But yet, the FDA is just diddling around with something really important. Pretty please, can you give us safety evaluations of bioengineered food crops? I’ll be your best friend…

The FDA is such a travesty, such an obvious industry mouthpiece, and they don’t even attempt to hide that fact anymore. Voluntary evaluations for biotech food. Mandatory labeling for Snickers bars. What is wrong with this picture?

“This doesn’t get us on the road to full mandatory testing, which is what we’ve been saying is needed,” said Joseph Mendelson III, the legal director at the Center for Food Safety. “It’s trying to put a Band-Aid on problems that need a wholesale fix.”

Amen, brother, I couldn’t have said it better.

In 2000, a genetically modified corn seed called Starlink mixed with other varieties of corn and forced several food companies to recall products. A worldwide drop in corn prices followed. Farmers and consumers sued Starlink creator Aventis SA and other companies involved with its development and distribution. The consumers said Starlink caused allergic reactions.

Mendelson said the new guidelines “are preparing us for the inevitable situation where more Starlinks happen. Essentially, the FDA is acknowledging that it will happen again.”

Not only is the FDA acknowledging that it will happen again, but they are encouraging it to happen again, because they refuse to regulate this industry. What kind of disaster has to happen before the FDA takes some action?

Five years ago, Dr. Joseph Mercola, who runs a popular website about natural and holistic health, issued a warning about Vioxx and other drugs like it.

You will see much in the media throughout the next few weeks about this new brand of drugs, COX-2 inhibitors. However, taking these new drugs might be a matter of exchanging a gastrointestinal risk from one painkiller to a cardiovascular risk for another. Though the cardiovascular risk may be much more significant.

I would strongly advise against using these drugs. I suspect there is a high likelihood that they will be pulled from the market when the increased cardiac deaths are recognized.

Also at that same time, a report in Proceedings of the National Academy of Science,stated that Celebrex may increase the risk of heart attack, stroke and blood clotting disorders. In the four years since these drugs have come on the market, there have been several reports and articles linking their use to an increase in cardiovascular events.

But did the FDA do anything to infringe on the huge windfall fortunes of these drugs? No, not a thing.

This whole Vioxx scandal also brings up the laxity of the FDA in monitoring drugs after approval. Some drug effects are not immediately apparent, as in the case of Vioxx, which took about 18 months to work its evil magic. The FDA needs to be carefully tracking new drugs for at least five years.

And who is to blame for this travesty? There are dozens of civil lawsuits being filed, but money payments only go so far. When responsible people start going to prison, then maybe we may start seeing some real regulatory action. Who at the FDA turned their back on this? Who ignored the data that was seeping in? Who delayed the recall of the drug?

Same goes for the manufacturer. I don’t know if this was the case with Vioxx, but oftentimes drug companies do not publish results of studies that show less than stellar results. This issue was highlighted when the connection between teen suicide and antidepressants was being examined. So was data on Vioxx suppressed? Did the data go through some statistical “engineering” to make it look good and play down side effects? Did they also cover-up information once the drug was on the market, that it may be dangerous?

Someone is responsible, but unfortunately, it seems like the FDA is being quietly acquitted of any wrong doing, and while Merck may have to make a few cash payouts, I doubt that there will be any criminal prosecution. What a shame.

It would be hard to ignore all of the fervor lately, over the drug Vioxx. But it seems to be business as usual with the FDA, and they are following their usual pattern of muzzling dissent within their ranks. Dr. David Graham, associate director in the FDA’s Office of Drug Safety, called the FDA’s approval of arthritis drug Vioxx, “The single greatest drug safety catastrophe in the history of this country or the history of this world.” Graham went on to cite the following statistic: A staggering 88,000 to 139,000 Americans suffered heart attacks and strokes as a result of taking Vioxx. He also pointed out that this number far exceeds earlier disasters such as the 100 children killed in the United States by an elixir of sulfanilamide in the 1930s and the 5000 to 10 000 children born in the 1960s with birth defects related to thalidomide.

He is the whistleblower. He is the person who is carrying out the function of the FDA, and doing the job that the agency is supposed to be doing.

So what happens? Tom Devine, Dr. Graham’s lawyer, stated that Graham would be exiled from his duties of reviewing drugs and placed in the office of the commissioner. Devine described this position as “filling space under the scrutinizing watch of a babysitter.”

Two good links to the story: USA Today, British Medical Journal

The BMJ article states that the approval of rofecoxib (Vioxx) by the US Food and Drug Administration has led to the “single greatest drug safety catastrophe in the history of this country or the history of the world,” charged one of the agency’s own experts, Dr David Graham, in US Senate hearings last Thursday

Dr. Graham also pointed out that sweeping changes were needed again because the FDA “as currently configured is incapable of protecting America against another Vioxx.” In response to questioning, Dr Graham indicated that five other drugs currently on the market may be endangering patients, including another cyclo-oxygenase-2 inhibitor, valdecoxib (Bextra; made by Pfizer), the weight loss drug sibutramine (sold as Reductil in Britain and Meridia in the United States), the lipid lowering drug rosuvastatin (Crestor; made by AstraZeneca), the acne drug isotretinoin (Roaccutane; Roche), and the asthma drug salmeterol (Serevent; A&H).

So in thanks for saving the public from yet more loss of life, Dr. Graham has been essentially demoted, and shuttered away inside of the commissioner’s office. Safe inside the commissioner’s office, he will be watched and kept out of mischief.

This is not a first for the FDA. When Dr. Mosholder was scheduled to speak out against the use of antidepressants in teenagers, and present some very thorough and damning evidence, he, too, was effectivly muzzled.

Although I don’t have the facts offhand, I can recall yet another story from a few years back, when a statistician was canned because his figures showed that a drug awaiting approval had basically no benefit. I believe it was one of those flu remedies, but he was summarily fired for his efforts.

Now we are hearing all kinds of nasty reports filtering in about the wonder drug Celebrex, which some experts have said is no more effective than the pain relievers you can buy over the counter at a tiny fraction of the cost.

If anyone has been following the sordid history of the FDA, somewhere along the way, they changed from the regulatory watchdog they were designed to be, into an agency designed to protect the financial health and welfare of the pharmaceutical industry. So who cares if a few people die from Vioxx? Better to cover it up so the manufacturer doesn’t lose any money, and stock prices don’t drop.