I think it's somewhat sad that it's been overly politicized, but I guess that's the price of doing something controversial in a country where the "religious right" has a lot more clout than is warranted. Politicians on both sides think the FDA has gone too far or hasn't gone far enough. I'd say that the agency has done a good job with their Plan B policy so far, if for no other reason than the fact that no one's completely happy with it.

Some of the nonsense on both sides is actually pretty funny, particularly when viewed with an eye towards history — especially the stuff from the right:

Coburn and other social conservatives said that the high doses of hormones in the pills carry risks, and that making them more easily available will encourage sexual activity and result in more unwanted pregnancies and sexually transmitted diseases.

That, my friends, is Grade A political BS. Opponents of oral contraception said the same stuff about "The Pill" when it first came out. It was then, and still is, a complete load of crap.

First of all, Plan B will prevent unwanted pregnancies. That's why it exists, and it does its job quite well. That whole STD thing… is anyone else having 1960s flashbacks here? Hello, these arguments were made when the pill first came out. They were unsubstantiated then, how is today any different?

"This is a bad decision for women, for girls, for parents and for public health," said Wendy Wright of Concerned Women for America, which led a campaign to block the decision. "The FDA's decision today will only make things worse for American women."

I'd love to hear the logic behind that one, backed up with some numbers. But wait, that'll never happen because the numbers won't be there, and the only thing the right will be able to come up with will be anecdotes here and there. And I'd put some serious money on that.

What does concern me is the current administration's emphasis on teaching abstinence. I think a rigorous sexual education program would go a long way in preventing STD transmission — but that, of course, is a bad idea because it will encourage teenagers to have sex. (Insert a humongous roll-eyes emoticon here.) Nevermind that the US has the highest rates of teen pregnancy and STD transmission of any first world country. Clearly the abstinence emphasis isn't working.

But the left isn't entirely reasonable either.

Plan B's backers, meanwhile, criticized the agency for not allowing the drug to be sold to everyone.

"We urge the FDA to revisit placing age restrictions on the sale of Plan B," said Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). But because the decision represents "real progress" and an "important step in restoring the American people's faith in the FDA," the senators said, they were lifting a hold they had imposed on von Eschenbach's confirmation as FDA commissioner.

I don't think it's a good idea for it to be sold willy-nilly to anyone that wants it. Ideally it'd be only sold to the person who is going to use it so its use can be more closely monitored, and the procedure for using it — and how it works — can be made clear to the woman who needs it.

So we've got Plan B available OTC. Now it'd be nice if the lay public got on the "Plan B is not abortion" bandwagon. Because it's not.

[tags]Medicine, pharmacy, Plan B, abortion, politics, healthcare policy[/tags]

My first post on bacteriophages was all a build-up to this piece of news that I found while perusing MRSA Notes.

A mix of bacteria-killing viruses may be sprayed on cold cuts, wieners and sausages to combat common microbes that kill hundreds of people a year, federal health officials ruled Friday.

The ruling, by the Food and Drug Administration, is the first approval of viruses as a food additive, said Andrew Zajac of the Office of Food Additive Safety at the agency.

[...]

The viruses, called bacteriophages, are meant to kill strains of the Listeria monocytogenes bacterium, the food agency said.

The bacterium can cause a serious infection called listeriosis, primarily in pregnant women, newborns and adults with weakened immune systems. In the United States, an estimated 2,500 people become seriously ill with listeriosis each year, according to the federal Centers for Disease Control and Prevention. Of those, 500 die.

Being bacteriophages, they don't attack humans. I say bring 'em on.

[tags]Medicine, food, phage therapy, bacteriophages, listeria[/tags]

"We know that an HIV-AIDS patient needs to take 95 percent of his or her pills or they won't work," said John C. Martin, chief executive of Gilead Sciences Inc., one of the companies in the Atripla project. "So the fewer pills a patient needs to take, the better the outcome."

Even I'm terrible at compliance, and I understand this better than most. I'd love to see some graphs that show the correlation between the number of times per day that a drug is taken vs compliance over time. I bet you see much higher compliance rates for a once-a-day drug than you do with twice-a-day regimens, and an even steeper drop-off when you've got someone who needs to take something 3 and 4 times a day. I bet it's particularly bad with 4 times a day dosing, because then you're not necessarily tying a dose to a specific daily activity (eating).

Hrm.

[tags]Medicine, pharmacy, Atripla, HIV, AIDS, Sustiva, truvada, patient compliance[/tags]

This cancer kills 3,700 women each year in the United States and hundreds of thousands more worldwide.

[...]

Gardasil, manufactured by Merck & Co. Inc., protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. It will be available by the end of June.

It is likely that Merck will market Gardasil as a cancer vaccine rather than an STD vaccine for political reasons. There has been some speculation that the religious right would opposed the vaccine if they thought that it would lead to premarital and/or teenage sex. To combat this, Merck launched their "tell someone" anti-HPV campaign several months ago to soften the social impact of the drug before the approval was granted. I'm sure we'll see Merck tie a new marketing campaign for Gardasil into this tell someone HPV campaign to allow a smooth transition from one to the other — despite their assertions to the contrary. Even if a direct connection between Gardasil and the tell someone campaign isn't made, Gardasil is currently the only vaccine approved to prevent HPV, so a woman asking about her doc about HPV prevention is almost akin to her asking for Gardasil — even if she doesn't know it. (Not that this is necessarily a bad thing.)

In any event, this is great news for everyone in the first world and the third. Hopefully this will mean that HPV-induced cervical cancer will finally go the way of polio. This is some of the biggest cancer news in a week already chock-full of cancer breakthroughs.

[tags]Medicine, pharmacy, Gardasil, HPV, genital warts, STDs, cancer, oncology, Merck, vaccine, cancer vaccine[/tags]

One of the exciting results announced at ASCO has been the affect of Tykerb on patients who have failed Herceptin therapy. The trial compared breast cancer patients on chemotherapy to those on chemotherapy + Tykerb. The results were that the 320 women who took Tykerb alongside their chemo went 4 months longer than those on just chemo without their cancer progressing. As a bonus, Tykerb is administered orally rather than intravenously.

GSK is expected to submit the findings to the FDA this year, and Tykerb could hit the market as early as 2007. Hopefully Tykerb will not get tripped up like Avastin did under further review. If it remains a success, Tykerb could be a very big seller, and benefit thousands of women in the US alone. In the future, Tykerb could compete against Herceptin more directly.

[tags]Medicine, pharmacy, ASCO, Tykerb, GSK, cancer, oncology[/tags]

This is just the latest trend in a newly-rekindled vaccination industry. Turns out there's money in vaccines after all.

But analysts reckon the vaccine market will grow much faster than the market for prescription drugs. "We're in a period where pharmaceutical sales are growing at 5% to 6% a year," says Novartis Chief Executive Daniel Vasella. "In contrast, the vaccine industry is looking at nearly 20% annual growth over the next five years."

I tend to take what analysts think with a grain of salt, because I get fed up with their near-obsessive emphasis on quarterly earnings, but they're probably right in this case. Biologics are heating up, and vaccinations are a big part of this. Along with expensive, niche biologic drugs, vaccines will probably be consistent money-makers for Big Pharma. The reason for this is is that it's quite difficult to get a generic biologic approved by the FDA. It can be done, but the FDA had to create a new way to approve these "generics," but this precedent of sorts may not hold water for other biologic generics:

The FDA said the approval did not set a precedent for other copycat biologics. Human growth hormone is one of the better understood protein compounds, making it possible to compare brand name and generic versions, it added.

"The approval of Omnitrope … does not establish a pathway for approval of follow-on products for biological products … nor does it mean that more complex and/or less well understood proteins approved as drugs under the Food, Drug, and Cosmetic Act could be approved as follow-on products," the FDA said in a statement on its Web site.

Unfortunately I cannot find the source of the quote, but in any event, it will be interesting to see what happens when more biologics start going off-patent. Will they still be big money-makers for Big Pharma due to bioequivalency issues? Or will have generic drugmakers have figured out ways around these potential roadblocks by that time?

It's easy to think that the generic companies will have figured something out by then, but I am reminded of the bioequivalency issues that generic manufacturers had with drugs like Lanoxin (digoxin) and Synthroid (levothyroxine) for quite a few years. It's not as easy as firing up a photocopier, particularly with complex biologic drugs.

Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I've talked about before, provided GSK doesn't pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don't think we'll see Imitrex tablets going OTC in this country anytime soon.

[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]

Overall, sales only increased 5.4% in 2005, down from an 8.5% increase in 2004. This data comes from Medco (the people behind the PAID PBM, one of the largest prescriptions insurers in the country), and their numbers cover a wide cross-section of the market, so they're probably representative of the industry as a whole. Big jumpers on terms of dollars spent were sleep aids: Lunesta and Ambien leading the pack, probably due in large part to direct-to-consumer advertising.

Curiosity got the better of me, and I did a little research, and here are the drugs that have either come off patent in 2006, or will in the next few months. The numbers in front are where the drugs listed stand on the top 200 list* for US sales:

• #2: Zocor
• #6: Zoloft
• #21: Pravachol
• #35: Allegra
• #44: Flonase
• Total sales: $13 billion

I suspect that we'll see a continuing downward trend when the numbers are released for next year. These drugs are some of Big Pharma's biggest hitters in terms of overall sales, and the total revenues for COX-2 inhibitors don't even compare to what is being lost in 2006. Great news for consumers and employers. Newer medications could pick up some of the slack, but super costly niche drugs like Humira and other monoclonals will never pack the revenue punch that widely-used statins, allergy meds, and SSRIs do.

* All numbers are from 2004, which is the most recent year for which data is available.

[tags]Prescription spending, COX-2 inhibitors, consumer spending, medicine[/tags]

Testing shows Gardasil is nearly 100 percent effective and works for at least five years, said Dr. Eliav Barr, Merck's head of biological clinical research. He said some of the first women and girls who got the vaccine will be followed for years to see if booster shots are needed.

The vaccine targets four of the roughly 40 types of human papilloma virus: HPV 16 and 18, which cause about 70 percent of cervical cancer cases, and HPV 6 and 11, which cause 90 percent of genital warts.

HPV is the most common STD in young women, and Merck has already begun running ads about the dangers of HPV — the company is of course prohibited from running ads about Gardasil until the FDA has approved it. A decision is expected by June 8, and when it comes down, Gardasil could become Merck's newest $1 billion a year drug. Bigger even than the money is the drug itself's potential: cancer caused by HPV is the #2 cause of cancer, killing over 300,000 women a year.

While pap smears won't be eliminated entirely, the drug could ease the discomfort of a million US women per year from having precancerous lesions removed. It is thought that two-thirds of cervical cancers could be prevented, but the exact number won't be known for probably 15-20 years after the drug is released because it can take that long for cervical cancer to develop.

Sometime in late June, the Advisory Committee on Immunization Practices will decide whether or not to recommend routine HPV vaccinations for women between the ages of 11 and 26. Vaccinations for men and older women will be considered if studies currently in progress indicate that it is effective at preventing transmission of the virus to sex partners. Current tests of Gardasil have it near 100% efficacy(!).

Money looks like it might be factor — at first, anyway — as each immunization will cost between $300-500, but I don't see many insurers balking too much if the clinical data supporting Gardasil's efficacy is there. As always, it is cheaper to prevent a costly illness like cervical cancer than to have to treat it later on down the road. Some insurers are finally coming to this realization when it comes to things like smoking. Instead of being reactive, insurers are slowly becoming proactive, because it's better for the health of their subscribers and also for their bottom lines.

As usual, though, there are those that might be opposed to the approval, namely the religious right who fear that Gardasil might send the wrong idea about premarital sex. (A ridiculous notion.) Fortunately, Merck has been able to overcome these fears with its anti-HPV campaign.

Merck's rival GSK is also currently testing a new vaccine, Cervarix, that works against HPV types 16 and 18. They hope to have approval for their vaccine by the end of the year, and they are also evaluating testing on other HPV types as well.

[tags]Gardasil, HPV, genital warts, STDs, Merck, Cervarix[/tags]

With the amazing assortment of drug interactions that MAOIs have, I question whether this is really beneficial for anyone. I can honestly say that I've seen one prescription for an MAOI in the last three years. With the advent of safer anti-depressants — the SSRIs — and the rightfully-earned stigma against MAO inhibitors, I wonder if Emsam really has a market. Sure there will be some sales, but given that it costs ~$500 million to bring a new drug to market, will it recoup its own R&D costs before its patent expires?

[tags]selegiline, MAO inhibitors, Emsam, SSRIs, anti-depressants[/tags]