"Glaxo Says Wine May Fight Aging " [New York Times]
(Photos: Getty)

The Ortho patch releases high levels of estrogen and can cause problems for some patients, but J&J says it's the FDA's fault for not requiring a label sooner:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company's own study showed the high estrogen releases. At that point, the product's label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

"We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner," Ms. Vanderham said. "Ortho Evra is a safe and effective birth control option for women when used according to the labeling."

But Janet Abaray, a plaintiff's lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

"Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies," Ms. Abaray said.

We travel full time, so to get our prescription meds we have used Walgreens, because they transfer prescriptions to any of their stores. In Dec of last year I had a prescription filled (for high blood pressure) at a Walgreens store in Dallas...I noticed that the pills looked different, but thought they must have changed to a generic. When I finished that 90 day supply, I got a refill at a Walgreens in Florida. Now the pills were back to what I'd taken for years...an oval green pill. I had 2 left in the old bottle, white round pills...not what that bottle label said they were suppose to be. Acckk! So now I had taken 3 months of the wrong mystery medicine.

I checked the PDR, no matches...I went to the local Walgreens and they couldn't identify it. Nor could the Poison Control Center. The local Walgreens gave me a phone number for Walgreens Corporate office, which led to another phone number and another, climbing the corporate ladder, finally speaking to the CEOs office (but not the CEO). I couldn't get anybody to understand that this was serious...that the pills needed to be identified, that it was important to know what I had taken, who else might have gotten the wrong med, how had this happened and more importantly what was being done to assure this wasn't still happening.

I tried to explain that if this had been a case of product tampering it would have presented like this...a pill not matching the description on the label. That in a case of product tampering people could have died waiting for their corporation to respond.

It ended up taking Walgreens six weeks to get the pill identified. It was a generic allergy pill that was a Wall Mart brand. There was no explanation of how it got in a Walgreens bottle. No explanation about any of this. And no assurances that they have improved any part of their system.

I wanted Walgreens to tell me what had happened... and what they were doing in the future to deal with this sort of mistake. People faced with this situation should immediately be given access to a person or department who will take this seriously. They should not have to wait SIX WEEKS to have a medication identified. And it should not have taken so much persistent effort on my part. Walgreens should have recognized this as an immediate problem, and responded quickly... with concern for my safety and others. They did not and have not done that.

According to PAL:

Medicare Part B recipients, health plans and individuals who paid for these drugs but were not on Medicare will be eligible to receive payments from this settlement once the Court finally approves it. The following types of individuals and entities will be eligible:

• Patients on Medicare Part B who paid a percentage (i.e. not a fixed copayment, but 10%, 20%, etc.) of the cost of one of the drugs in the case, taken between Jan. 1, 1991 and Jan. 1, 2005.
• Health Plans and other Third Party Payors who paid all or part of a Medicare Part B recipient's percentage co-insurance for one of the drugs.
• Individuals not on Medicare Part B who paid all or part (a percentange) of the cost of one of the drugs taken between Jan 1, 1991 and March 1, 2008.
• Health plans and other Third Party Payors who paid all or part of the cost of one of the drugs taken by an individual not on Medicare part B between Jan 1, 1991 and March 1, 2008.

"11 drug companies settlement AWP allegations for $125 Million" [Prescription Access Litigation]
(Photo: Getty)

"We need a way to synthesize data about the effectiveness of health care products and services in a standardized, objective fashion that will be considered reliable and trustworthy by all decision makers," said Dr. Barbara McNeil of Harvard School of Medicine, who worked on the report.

"A system coordinated by a single, national entity that can prioritize and coordinate these evaluations would enable us to sort the wheat from the chaff and make sense of it all," McNeil said in a statement.

"Report seeks one-stop source for health info" [Reuters]
(Illustration: Getty)

Enbrel is a redonkulously expensive injectable drug that "has an annual cost of about $16,000 for a psoriasis patient."

"Amgen salespeople allege improper Enbrel promotion" [Reuters]

The study shatters the accepted myth that pharmaceutical companies spend more on research than on marketing. In reality, drug companies pour $57.5 billion into marketing, dwarfing the comparably paltry $31.5 billion devoted to research.

Billions of marketing dollars go toward television ads that implore us to "ask our doctor" about drugs we don't need to treat ailments cultured by public relations firms. Yet even more money is spent convincing doctors to prescribe costly medicine—an astounding $61,000 in "promotion per physician."

For the last 50 years, say the authors, there has been an ongoing debate as to which image of the drug industry is most accurate. The industry promotes a vision of itself, say the authors, as "research-driven, innovative, and life-saving," but the industry's critics contend that the drug industry is based on "market-driven profiteering."

The study confirms the more cynical view that drug companies are out to profit first, and save lives second. And there's nothing wrong with that.

Don't be ashamed to ask your doctor if a drug company recently paid for any meals or ski trips. Instead of mentioning the latest drug splashed across the screen, ask how they would use their expansive medical knowledge to treat your condition. Ask how they would treat their child.

Do drug companies do more marketing or research? [SciGuy]
The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States [PLoS Medicine]
(Photo: rabbit.marshall)

Things not to do with Duragesic, according to the agency: don't use it for "occasional or mild pain, post-surgical pain, or for headaches." Don't expose it to high heat, such as in a hot tub, and don't use more patches than prescribed or apply them more frequently.

Michael Cohen, president of the nonprofit Institute for Safe Medication Practices, said the new FDA warning "will educate some doctors, but it's not enough. I think we need to do more." Cohen said other steps could help such as requiring pharmacists to discuss proper use with patients, or having company salespeople do more to get the message to doctors.

Signs of a fentanyl overdose may include breathing trouble, slow or shallow breathing, slow heartbeat, severe sleepiness, cold, clammy skin, trouble walking or talking, or feeling faint, dizzy, or confused. Patients should get immediate medical attention if those signs occur, the FDA said.

Even the FDA has mixed feelings about it, which it may resolve this week.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu has been more widely used in Japan than in the United States, and there is some evidence that the Japanese are more vigilant about reporting side effects, the FDA has said.

FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

The new Tamiflu warning would state: ""In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

For Relenza, the proposed warning would caution that "reports of hallucinations, delirium and abnormal behavior" have been observed in some patients.

"FDA staff urge psych warnings for two flu drugs" [Reuters]
(Photo: Getty)

Incidentally, Zocor is the cholesterol-lowering drug that recently lost its patent protection, leading to a burst of business for the generic version of simvastatin and a steep drop-off in profits for competitor and market leader Lipitor. (For the record, Lipitor is a third kind of statin, called atorvastatin.) Pfizer, the maker of Lipitor, has been trying hard to persuade consumers to not switch to generic Zocor—maybe now they have a new bit of ammo to use in their argument, at least for those who aren't getting any rest.

"Sleepless? Maybe it's your statin" [Reuters]

RELATED
"Pfizer Launches Campaign To Warn Users Away From Generic Competitor"
(Photo: Getty)

"Ferret waste, like nearly any other form of pet waste, can be effectively used to help prevent the abuse of unused prescription drugs," SAMHSA spokesman Mark Weber said.

Some suggestions: turn your clock around so you can't watch time pass; don't eat, read or watch TV in bed; avoid caffeine and alcohol before bedtime; light-proof your windows; get up at the same time every morning; and if you can't fall asleep after 15 minutes, get up and find something boring to do. (We guess you just estimate the amount of time that's elapsed, since your clock is facing the other way.)

Some of these suggestions are meant to train your brain to equate "bed" with "sleep time," while others are meant to prevent your central nervous system from becoming "hyper-aroused." Funny, we thought that stopped after puberty. (Rimshot!)

"Curing Insomnia Without the Pills" [New York Times]
(Photo: Getty)

The article isn't clear on whether or not the drug is entirely imaginary, or whether it's actually being sold as a treatment for diabetes. But either way, it's an over-the-top scam—and, what with the executions and all, we think a dangerous one to pull in China. It even managed to get a Chinese official to speak in English idioms, according to the article's quote:

"This site is definitely not for real," an official at the regulator was quoted as saying. "These lawbreakers have got some balls!"

"Fraudsters fake Web site of drug watchdog" [Reuters]

RELATED
Real Chinese Health & Drug Website
Fake Site

One of strongest claims Pfizer is making is that patients who switch have a higher risk of death, but the in-house study they cite is being criticized by doctors:

But independent researchers say that limitations in the study, which was conducted by Pfizer's own researchers, gives it little predictive power about what will happen to patients who take simvastatin instead of Lipitor. And they say the study is far less important than large clinical trials that have shown simvastatin's effectiveness at reducing cholesterol.

Of course, your doctor will know better than a blog whether you should switch:

For patients with extremely high cholesterol, Lipitor may be a better choice. An 80-milligram daily dose of Lipitor, the top dose, can reduce cholesterol by up to 60 percent, compared with about 50 percent for an 80-milligram dose of simvastatin, also the top dose."

There's still no clear evidence that taking the drugs actually causes hearing loss. "We don't know enough to say that it's ironclad caused by the drugs, but we see enough to say we can't ignore it either," said an FDA doctor.

Viagra already includes a warning about this on their label.

"FDA warns Viagra tied to hearing loss" [MSNBC]
"FDA adding hearing loss risk for impotence drugs" [Reuters]
(Photo: Getty)

The patients in the study were selected from three community health centers in Michigan and were all taking high blood pressure medications. The average age was 55.

The author of the study suggests that patients bring their prescription bottles with them if they visit a hospital, and carry the name and number of their pharmacy so that any questions can be quickly answered. We think these tips are especially important for the elderly, which is why we're going to make our grandmother a "pill vest" for Christmas with three dozen little pockets on it for all her prescriptions. (Hi, grandma!)

He also suggests that generic drugs be given simple, easy-to-remember and easy-to-pronounce names just like name brand drugs, since many people have trouble with the multi-syllable chemical names they're usually sold under. Do any health professionals on the site know whether there are legal issues preventing this?

"Name that drug: Many patients can't" [Reuters]
(Photo: Getty)

Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes or heart problems after taking the drug, although Lilly says that Zyprexa has never been proven to cause diabetes. At least 1,200 more lawsuits are still pending.

"Lilly Adds Label Warnings for Mental Illness Drug" [New York Times]

Several trade and professional groups support the idea, including the National Community Pharmacists Association and the National Association of Chain Drug Stores. The FDA points out that pharmacists have the necessary training to educate consumers about how to use certain drugs, and that a BTC category would help people without health insurance gain access to certain medications.

The one huge down-side we can see to this: big pharma will start targeting pharmacists with freebies and samples to pass out to customers—we can imagine going to get a BTC drug in 2009 and being met by a pharmacist wearing more pieces of "Ask Me About [Drug Name]" flair than Jennifer Aniston's nemesis at Chotchkie's.

"FDA explores behind-the-counter drug sales" [Reuters]

RELATED
"US FDA Considering 'Behind-The-Counter' Drug Status" [CNN Money]
(Photo: Getty)

The chairman of the department of medical ethics at the University of Pennsylvania says, "In many ways, rats and mice get greater protection as research subjects in the United States than do humans."

Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said. Because no one collects the data systematically, there is no way to tell how safe the nation's clinical research is or ever has been.

"Report Assails F.D.A. Oversight of Clinical Trials" [New York Times]
(Photo: Getty)

• Issue mandatory recalls;
• Limit food imports to ports clustered near FDA inspection labs;
• Require a country of origin labels for food, drugs and medical devices;
• Subject exporters to a strict certification program administered by the Department of Health and Human Services.

Start hitting refresh at 10 a.m. for up-to-the-minute coverage of overly politicized opening statements and excessively verbose questioning.
(Photo: Associated Press)

9:40: Video Link
10:07: And we're off! Chairman Dingell must be sleeping in - Frank Pallone of New Jersey has taken over his seat.

10:09: Pallone is addressing a Presidential Working Group that we already covered. Their report tells us nothing we don't know.
10:11: He's staying fair and balances. E-coli contaminations and the infamous Peanut Butter Recall of 2007 were caused by domestic producers, not foreign factories. A stronger FDA could address these recalls as well.
10:14: Nathan Deal (R-GA) is talking. Not that our site is loading, or anything like that. So we'll just write for ourselves for a bit.
10:16: Gene Green (D-TX) needs to go to media school. This guy is making all the classic mistakes: rushing through his statement, reading into the paper... we haven't seen eye contact yet. His points about Houston getting shafted by the requirements to bring imported food only into select cities have been completely lost to his poor speaking skills.
10:18: His solution: open a FDA lab in Texas. For reference, there are only thirteen labs in the U.S. One, as Green is pointing out, is located in Jefferson, Arkansas. Come on, Arkansas, get one of your reps up there to defend your pork lab.
10:20: Michael Burgess (R-TX) is going China-hunting. He worried about carbs in the '90s, but now, (cue ominous music) he worries whether his groceries will make him sick. Tear for the scared Congressman.
10:23: Someone's angry that their Subcommittee didn't get to hold a hearing. Chairman Dingell need not yield to Subcommittees. He's the Dean of the House. When he introduces a bill, he can have the full Committee hold an immediate hearing. Sorry, Congressman Burgess.
10:25: Congresswoman DeGette (D-CO) has made a sad comparison. People are surprised that the CPSC can recall toys, but the FDA can't recall baby food. Please, don't ever hail the CPSC recall procedures as ideal, or better than something else. Just compare everything to the USDA's relatively amazing power to recall everything on demand.
10:27: Mike Ferguson thinks it's impressive that citizens trust the government to inspect food. What?
10:28: Ferguson worries about counterfeit drugs pushed by the Chinese Poison Train. "We need to examine the origin of these drugs." Pst, Congressman... they come from China!
10:29: Hey look, the tech gods have revived our site. Every time the site goes down, I look around my shoulder and expect to see Verizon man wearing an evil grin.
10:31: Dingell has risen, but not really. He's propping his head on his hand. The former Army Second Lieutenant always sounds like he's barking orders.
10:32: He has compared our inspection regime to a block of swiss cheese. We award no points for originality.
10:33: He has heard from the FDA that they will improve since he has arrived. "It is as much a bunch of hooey now as it was then."
10:34: A small user fee ($50 on food shipments, $1,000 on drug shipments,) is necessary to fund FDA inspectors, labs, etc.
10:35: "I would observe that the credo down there seems to be "Trust Us."
10:38: John Sullivan (R-OK) believes that reused chopsticks and support for the Taliban show that China is not a friend.
10:39: One clever fox from California just held their opening statement time so they could ask additional questions later. That means fireworks.
10:41: Jan Schakowsky is giving her opening statement. We still wish she bothered to show up for last week's hearing to chew out Mattel CEO Robert Eckert like she promised.
10:42: Jan also doesn't like limiting imports to certain ports, excluding ports like Chicago. What? Since when does the port of Chicago receive goods from China?
10:44: Heather Wilson (R-NM) is wearing a greenish-blue thing straight of the 1950s. Way to wear your values, Congresswoman.
10:50: Steve Buyer (R-IN) is mistaking a Congressional hearing for the first day of second grade. "In three minutes, I can't even begin to cover what I did over the summer."
10:53: "We propose giving the FDA the power to destroy fraudulent drugs coming into our postal system." Sounds more fun than it is.
10:56: Jim Matheson (D-UT) thinks the solution to the Chinese Poison Train is bipartisanship. Um, yeah. Care Bear Stare!
10:58: Marsha Blackburn (R-TN) is talking. 1.7% of goods were inspected in FY06. Not much more than FY07.
11:00: Blackburn has a few concerns, namely, everything in the bill. "I look forward to the discussion."
11:03: OMG, Congressman Buyer (R-IN,) there are fake drugs on the internet? No! It must be a lie! Damn Canadians, trying to kill us every chance they get.
11:07: Buyer is playing with drugs.
11:08: Statistically improbable phrase of the hour: flim-flam man (shady internet pharmacist.)
11:09: Our first coffee break of the morning is approaching. A vote on the floor will soon recess the Committee for a bit. Still haven't gotten to the first panel.
11:10: Why do all Members have the urge to regurgitate the bill's main points. We know the bill imposes mandatory country of origin labeling. We know it limits ports and imposes user fees. Resist the urge to tell us for the millionth time.
11:11: Coffee break. The Committee will return in about twenty minutes.

11:39: The hell with opening statements, we're going straight to the panelists.
11:40: First up, Randall Lutter, FDA Deputy Commissioner for Policy
11:43: He's also lauding the Presidential Working Group, the one that concluded inspections are a waste.
11:45: The FDA, like the CPSC, is meeting with Chinese officials to hammer out a Memorandum of Understanding. China regularly ignores MOUs with the CPSC.
11:46: "I would like to comment briefly on H.R. 3610." Isn't that why you're here, Deputy Commission?
11:48: Green wants to know how the FDA decides where to put its labs.
11:49: Lutter isn't sure, but he knows the FDA plan to consolidate labs is shelved (thanks partly to Dingell's threat to ban the consolidation in this bill.)
11:50: Green wants mobile labs sent to Texas.
11:51: The bill allows the FDA chief to issue a waiver regarding the port inspection provision. Green thinks that will result in an influx of waiver requests, but the FDA hasn't examined that part of the bill. Is that their strategy? We can't comment because we haven't read the bill?
11:53: Good catch, Mr. Deal: "Your written testimony doesn't seem to cover the legislation covered by this hearing. When will the Administration provide a written response? "
11:53: Lutter: "It looks like a matter of some weeks."
11:55: The user fee structure is based on line item. A line item is a shipment that comes in as one commodity under one part of the tariff code.
11:56: Mr Deal: "Does that mean an ethnic restaurant using lots of products would be subject to multiple user fees?" Do most ethnic restaurants import their raw ingredients from abroad? We're pretty sure that's not how it works.
11:57: The video link appears to be suffering from Mad Cow.
12:07: The video link has been restored. All rejoice.
12:10: Israel, Costa Rica, and Vanuatu have caught fake pharmacies shipping to the U.S. that claim to be Canadian.
12:12: Good news, kids. The FDA is especially concerned about leafy greens. Didn't stop us from enjoying a yummy kale and cheddar omelette this morning.
12:13: Another recess. Back in twenty.

1:01: That was not twenty minutes.
1:02: Dingell is shooting off a line of questions. Yes or no answers only.
1:04: Dingell's favorite phrase: "Please submit that to the record."
1:10: Pallone wants to know what new authority the FDA wants.
1:16: There's an active dialogue within FDA about what new powers they want, but they really don't want to share any details with the Congress.
1:18: "User fees are a double-edged sword." Yes, they cost businesses money, and they fund government activities.
1:19: We're clearly not dealing with the CPSC.
Pallone: Your resources are adequate, right?
FDA: Yes, they certainly are.
1:22: 5% of packages going into the FDA bin from FedEx and UPS are inspected.
1:23: The bin lets the Agency flag certain suspect shipments for inspection.
1:24: Detained products receive a mark. Buyer wants to know why products with a mark are continually shipped back to the U.S.
1:26: Counterfeit products that are not destroyed are returned to sender.
1:26: Buyer: Do you think that's a good policy?
FDA: We're concerned about the continued circulation of counterfeit products.
1:28: The FDA is willing to accept the power to destroy more products, providing that cost and due process are addressed by Congress. Sounds like a fun job.
1:30: DeGette is taking the opportunity to shill for her Denver lab. "They don't want to move to a centralized lab. Those people will all quit."
1:31: Degette: "When can you get back to me about when you can get back to me about the analysis?"
FDA: Sometime next week?
1:33: The FDA would accept more resources to inspect more items coming in, so long as it's part of a broader proposal.
1:34: By mid-November the FDA thinks it'll know how much more cash they need.
1:38: The certification regime will require the FDA to certify that exporting nations have the same or equal quality control measures as we have. Individual companies would be able to gain certification for individual facilities. Doesn't sound like it would address subcontractor problems similar to Mattel's.
1:41: FDA: "It's not something you can throw money at, flick a switch, and expect to be fixed."
1:45: The first panel is dismissed.

1:53: Onto the second panel, which has eschewed nameplates. Watch as we struggle to track who's who.
1:54: Former Congressman Calvin Dooley, now representing the Grocery Manufacturers Association is arguing that the problem is really quite small. Needle in a haystack small.
1:57: Surprise, surprise. They oppose a user fee. "Food safety is a public good, and should paid for out of the general fund."
2:00: Dooley is making a terrible point about how groceries would have to pay two separate user fees for two similar products. He holds up two boxes of vegetarian chile made by two different manufacturers. According to Dooley, the user fees on those two boxes would cost $100, but you don't import one box. You import a crate, a shipping container with a few hundred or a thousand boxes. So it's not $50 per box, it ends up being $0.05 per box.
2:04: The Food Marketing Institute, of course, opposes user fees as well.
2:07: Pallone tells FMI to wrap it up. Dooley zoomed past his time limit, which is ok because he's a former Congressman.
2:08: Another recess.

2:50: Oh, they bothered to return. How kind of them.
2:53: The Center for Science in the Public Interest, one of our favorite advocacy groups, is worried that the user fees will end up being a side show that distracts from other issues. That sounds about right, but might be intentional. It's the old Thomas Crown two-step: "...make a lot of noise over there, so over here in this room you can take 100-million off the wall and waltz right out the front door. Oh, that's good."
2:54: Big Pharma is talking, but in all honesty, we don't feel compelled to repeat their bleatings here. Feel free to get a cup of coffee and we'll let you know when Members are ready to question the other panelists.
3:16: Pallone asked everyone to defend their opposition to user fees. Upon hearing their responses, he quipped: sounds like the previous objections we have heard, but we did it anyway because we weren't sure where they money would come from.
3:23: More questions for Big Pharma. Suffice it to say, the FDA is under tremendous pressure to combat counterfeit drugs.
3:30: Matheson is making an excellent comparison between food safety and toy safety. Both require improving oversight over supply chains and the imposition of some inspection regime, either from the government or the private sector that can assure the quality and safety of goods destined for our shores.
3:38: The hearing is adjourned.

The visual hallucinations frequently consisted of seeing people or scenes. One patient reported seeing flying objects, another saw scenes of Montana and New York City, and a third patient saw a giant "Wookie" from the movie Star Wars bending over his bed. The auditory hallucinations often consisted of hearing voices and music, and one patient reported hearing TV commercials.

But back to the hallucinations: we wonder if taking large doses of vitamin C along with the treatment would make them any more intense?

"Hallucinations not unusual with antifungal therapy" [Reuters]
(Photo: Getty)

It's the only area of health care that hasn't risen sharply, says the New York Times, and it's at least in part because more consumers are turning to generic drugs, and because new generic versions of popular drugs are coming out. But there's also speculation that Wal-Mart's $4 generic drug program, which it launched last year, has helped. For one thing, it's prompted competitors like Target and Kmart to offer or expand their own discount programs. But it may have also helped drive market prices down. One Labor Department economist said he noticed a dramatic drop in generic drug prices after the $4 plan was launched.

Earlier this month, Wal-Mart announced that they'd offer their employees 2,400 $4 generic drugs, over 2,000 more than what they sell to the public. The Labor Department economist says the drop could be a one-time phenomenon unless the big discounters expand the number of drugs they offer. Nobody knows whether or not that will happen, but Wal-Mart has said that later this month "it may make an announcement regarding its generic drug program for consumers." In the meantime, look at our earlier post on how to find the cheapest drugs.

"Helped by Generics, Inflation of Drug Costs Slows" [New York Times]
(Photo: Getty)

The bill was sparked largely by problems with the anti-inflammatory drug Vioxx, sold by Merck & Co Inc., which was linked to heart attacks and strokes in some patients.

Some other features of the bill:

• It increases the amount that pharmaceutical companies will have to pay to support FDA safety studies—about $87 million more than current levels beginning October 1st of this year;
• It requires pharmaceutical companies to pay $225 million over the next five years to support FDA safety monitoring for drugs that have reached the market;
• It requires drugmakers to place the results of their clinical trials for approved products in a public database;

"House clears FDA drug safety, fee bill" [Reuters]
(Photo: Getty)

(Photo: Getty)

According to the FDA, most brand-name drugs receive patent protection for 20 years, though there is a large lead time between the submission of a patent and the sale of a drug. Most drug companies enjoy their patent protection for only seven years, at which point generic drug makers, who do not need to recoup the cost of development or marketing, step in and offer the same drug for a third of the price.

The Senate Health, Education, Labor and Pensions Committee will mark up the proposal on Wednesday. — CAREY GREENBERG-BERGER

Lawmakers Offer U.S. Plan for Generic Biotech Drugs [Bloomberg]
Write Your Senator
(Photo: e-magic)

The study was outed yesterday on the New England Journal of Medicine's website. The editors of the journal and the study's lead author both warned that the research methodology left the "findings open to interpretation."

Even though the FDA was aware of the risks since last summer,

...the publication of the study on the journal's Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

The FDA is trying to defend itself against comparisons to its handling of Vioxx by pointing out that it is almost done with its own independent review of the study. That isn't enough for several members of Congress.

The House Energy and Commerce Committee has already asked why the Agency couldn't warn the public while the study was underway. Congressman Henry Waxman, Chair of the House Committee on Oversight and Government Reform, plans to haul the head of the FDA, Andrew von Eschenbach, before his committee for questioning.

Patients on Avandia may want to call their doctor. — CAREY GREENBERG-BERGER

Heart Attack Risk Seen in Drug for Diabetes [NYT]
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes [New England Journal of Medicine]

But surely, Merck would have learned it's lessons and come up with a safer drug to fill the Vioxx void, right? Right?

Apparently not. David Graham, a lippy FDA insider, is blasting Arcoxia as being just as risky to the heart as Vioxx. He also accused Merck of routinely engaging in "misdirection and disinformation presented in the guise of science." And this is the same guy who told a Senate committee in 2004 that the FDA was "virtually defenseless in preventing a tragedy and profound regulatory failure" such as Vioxx.

Although Acroxia's currently not on pharmacy shelves in the States, it's already on sale in 62 other countries around the world. So as impotent as the FDA is to prevent us all from croaking, we can at least take comfort in the fact that many other countries are even worse about regulating the pharmaceutical industry.

FDA Critic Blasts Merck's Vioxx Replacement [Consumer Affairs]

As if it weren't enough that they swelled up horribly, tore at their flesh, and had to have their toes amputated, recent tests show they have no detectable T-cells.

Without toes, you can't walk. Without T-cells, the victims are susceptible to a variety of auto-immune diseases where the body attacks itself.

This is the very condition that the drug was designed to treat.

Having paid a nominal sum to the victims, Parexel denies further liability. Some of the patients are suing, but they may not live to see their legal effort's fruition.

Renewed ordeal of the Elephant Men The Sunday Times. (Thanks to Francis!)

When companies like Eli Lilly or Pfizer sponsor a study, they almost invariably come out on top as more effective than their rivals. Comparatively, federal studies often show that drugs not under patent are the most effective in treating illnesses.

Studies sponsored by drug companies try to stiff the competition by using too low dosages on competitors' drugs, or very specific statistical or clinical wording to make their drug shine through.

So doctors depend on clinical studies to prescribe the right medicine, but those clinical studies are essentially advertisements Well well well. First diseasemongering, now buying clinical trials off. What will the pharmaceutical industry think up next?

Drug studies skewed toward study sponsors [Washington Post]

Only 9,650 suits and 19,000 plaintiffs to go. Merck had $6 billion in profits last year.

photo: John McDarby's wife, facing front, hugged by lawyer after damages awarded.

"Merck Jury Adds $9 Million in Damages" [NYT]

In short, my father meant ADD is a scam — a nice handy catch-all phrase to justify medicating kids who don't conform or pay attention. It's also a handy excuse for not living up to expectations.

On that note, the Public Library of Science has identified ADD as a disorder that the pharmaceutical industry is "diseasemongering" — an industry term for promoting non-existent illnesses, exaggerating minor illnesses or treating risk factors as diseases to sell medication. They've also identified osteoporosis, female sexual dysfunction, restless legs syndrome and anti-impotence medications as examples of diseasemongering.

PLoS's well designed website is full of articles justifying their claims. They warn that diseasemongering actually decreases public health awareness, essentially being an industry sponsored case of hypochondria, detracting resources and attention from serious disorders.

Drugs companies 'inventing diseases to boost their profits' [Times Online]
PLoS Diseasemongering Website

Let loose the horsemen! The seventh seal has been broken! Atlas shrugs, yes, it's it's... NEW CHEWABLE VIAGRA. Duhn duh duhn!

"Viagra Soft Tabs are mint flavored soft tablets for the treatment of male erectile dysfunction. They are equivalent to regular Viagra , however due to their soft formulation, they are absorbed directly into the bloodstream," reads the website offering "Special Internet Prices" (who knew reading your spam could be so informative?).

The next logical step is to go the way of Altoids and Listerine and concoct dissolving Viagra mouth strips. Or, darn it all to heck and back in a Chevy droptop, do some ecstasy rails.

Of course, the chewable Viagras are bound to fail. It's target audience has a hard enough time gnawing through the all-bran Quaker Oatmeal in the morning.

UPDATE: Inspired, Mark Duffy wrote in some killer taglines:
"Getting Harder Has Never Been Softer."
"The Chewable Way To Be Fuckable."
"By The Time You Swallow, It Will Be Her Turn..."

"Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines."

That's from an article published today in the Public Library of Science Medicine online journal, claiming that experiencing drug advertising could be hazardous to your health— and your wallet:

"DTCA is limited to drugs that are profitable to advertise: mostly expensive, new drugs for long-term use for common indications. Such advertising increases premature rapid uptake and overuse of new drugs before flaws, including safety problems, have been discovered and communicated to health professionals... Many new drugs are inferior to older treatments, and over two-thirds are no better but are often more expensive..."

Does this mean our new Placeberol prescription won't cure urban decay like the commercials seemed to promise?

Read More: What Are the Public Health Effects of DCTA? [Public Library of Science Medicine] (Thanks to EPIC.org!)

Some more details are coming out about the clinical trial, which has put six men into the hospital, two of whom are not expected to recover. Raste Khan, one of the men who received the placebo, has described the experience of watching his peers drop like flies as "like Russian Roulette".

"This one man was yelling 'doctor, my head hurts, my back hurts. I need help, I can't breathe.' He was just shouting and rambling to himself," said Khan, one of two men given a placebo.

"Everyone was continuously vomiting," Khan said in an interview broadcast Thursday on Sky News.

"It was like Russian Roulette — two of us got away and were lucky."

Another person who applied for the clinical trial but did not decide to participate had this to say:

"I went through and read ... the consent form they got me to sign while rushing me. It didn't really explain it fully in there, so when I tried to contact them, there was no answer and no return of my message so I just left it at that and decided not to pursue it."

When we reported on this story yesterday, some of you seemed to think we were insinuating that TeGenero meant for this to happen. Of course they didn't. That doesn't change the fact that this sort of thing should not happen in properly conducted and researched clinical trials. Quotes like the above make it extremely obvious that this was neither. You don't get fucking sloppy with people's lives.

Drug test 'like Russian Roulette' [CNN]
Related: Drug Trial Goes Horribly Wrong

BBC reports, "But relatives are said to be unhappy with the information given from the firm behind the anti-inflammatory drug."

"Ms Marshall [pictured], 35, whose boyfriend is critically ill, said the normally healthy 28-year-old's face was so puffed, he "looks like the Elephant Man".

Soooo, it's an anti-inflammatory drug and his body is badly swollen... that would strike us as humorously ironic if we weren't so busy crying.

"Lawyer Ann Alexander, representing one of the critically ill men, told the BBC the companies had been asked whether any of the animals used to test the drug had died.

"I understand that yesterday, they were told a dog had died during the testing. Today that was denied," she said."

Right, so if a pooch dies during testing, that's usually a pretty good sign that the drug isn't ready for human use.

"A day ago I was talking to him and he was fine and now they are saying he could die at any moment," said Ms. Marshall.

From The Independent:

"One victim was named as trainee plumber Ryan Flanagan, 21, of Highbury, north London. His family were told he could not breathe unaided, and his head and neck had swollen to three times their normal size."

"Raste Khan, one of two men taking a placebo who was unharmed, said his co-subjects "went down like dominoes". He told The Sun: "First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode. After that they started fainting, vomiting and writhing."

A former student described yesterday how he nearly took part in the Parexel trial but dropped out of it.

But he felt rushed. ''Something told me to be suspicious about it even though I did not know why I should,'' he said. ''It seemed a bit haphazard.'"

Two Drug Trial Men Critically Ill [via Digg]

"The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients...the drug's users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands," reports the New York Times.

A night nurse who took the drug describes one such experience. "One day," she said, "I got up my husband describes this in great detail I got a package of hamburger buns and I just tore it open like a grizzly bear and just stood there and ate the whole package."

So you can't sleep and you take Ambien. But you get fat from sleep eating so you take diet pills. Then you're depressed and anxious about your sleep disorder and weight gain and embarrassed about your new chemical dependency. So you take some Xanax.

Then one day, you eat an Altoid. All the drugs in your body chain reaction and you transmogrify into a tiny pill, clattering to the floor. Pfizer collects the capsule and prescribes it to immigrants to help them feel more American.

Study Links Ambien Use to Unconscious Food Forays [New York Times]

The U.S. and its wealthy allies are moving to approve a first-of-its-kind plan to encourage pharmaceuticals companies to develop vaccines for diseases that afflict countries too poor to afford them.

Finance ministers from the Group of Eight major industrialized powers, who met here this weekend, expect to approve a pilot project when they next get together, in Washington in April.

Under an advance market commitment plan, the G-8 nations would promise to subsidize the purchase of new vaccines — for between $800 million and $6 billion — if pharmaceuticals companies develop ones that meet standards of efficacy and safety. Once the G-8 spends the pledged amount, the drug companies would sell the vaccine at a set discount in the developing world.

In each of three different studies, participants were given energy drinks that supposedly make consumers feel more alert and energetic. Some participants paid full price for the drinks; others were offered them at discounted prices. The participants were then asked to solve a series of word puzzles. In all three studies, the people who paid discounted prices consistently solved fewer puzzles than the people who paid full price for the drinks.

So when Grandma has to eat canned cat food 'cause the HMO's are bending her over the Formica, at least she can take comfort in knowing that her mind is causing her medication to work to its fullest effect.

Were these studies run with a control group? That is, the results compared with identical studies run by a group of researchers whose future livelihoods don t depend on bloating profit margins?

Paying higher prices isn t just patriotic—it s better for you.

You Really Do Get What You Pay For [Stanford Graduate School of Business via Consumerworld]