Some people have very sparse eyelashes, and this can cause functional problems with the eye as well as anxiety about one’s appearance. Fortunately for people suffering from ” eyelash hypotrichosis,” a brand-new treatment was approved by the FDA in December 2008. The product is called Latisse, it has sultry-eyed [...]]]>

Some people have very sparse eyelashes, and this can cause functional problems with the eye as well as anxiety about one’s appearance. Fortunately for people suffering from ” eyelash hypotrichosis,” a brand-new treatment was approved by the FDA in December 2008. The product is called Latisse, it has sultry-eyed Brooke Shields as a spokesmodel, and it is a 0.03% solution of bimatoprost marketed with an applicator brush.

Latisse is meant to be dabbed along the base of the upper lash line (the lower is too sensitive), causing hair there to grow in much more thickly and darkly than before. Its effects are not permanent, and if it is discontinued, the lashes will return to their original condition within weeks or months.

Technically, bimatoprost is a prostaglandin analog that affects eye pressure. As a generic, and under the trade name Lumigan, the solution is used to control the progression of glaucoma and manage ocular hypertension. Although the main ingredient is the same, using bimatoprost or Lumigan, which are serious ocular pressure meds, to lengthen or grow eyelashes is an unapproved, off-label use. (In fact, eyelash growth was a surprise side effect of these meds.) Some are tempted to swap these pharmaceuticals freely, but doctors warn that it can be harmful to your health profile and insurance history to be have a history of ordering glaucoma drugs when you are merely trying to treat a cosmetic problem.

Commercials for Latisse have been in heavy rotation on television and in glossy women’s magazines lately. If you aren’t paying close attention, you might think you are looking at a mascara ad, but mentions of the treatment being the “first and only” treatment approved by the FDA to treat hypotrichosis make it clear that this is not just make-up. The glam may have gone a little too far, though, says the FDA. MSNBC reports:

Last week, Latisse made headlines when the FDA sent a warning letter to Allergan stating the promotional materials posted on the product’s Web site were “misleading because they omit and minimize risks associated with Latisse.” Among the risks, the FDA notes, is that the active ingredient can cause hair to grow in other places besides the lash area, cause inflammation of the cornea — and can make lighter-colored eyes turn brown.

Meanwhile, an article at BNET says the FDA also accused Allergan of downplaying infection risks.

We went directly to the Latisse website to get their own description of the side effects. Here’s a summary: About 4% of users experience itchy and/or red eyes. Less common side effects include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids. It is very important not to use Latisse directly on the eye, or on the lower eyelid. It should only be applied to the UPPER eyelid with a sterile applicator. Latisse may cause darkening of the eyelid skin which may be reversible, and it may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.

The information is there, but not particularly prominent. Changing the color of the eye is a huge side effect, and we’re curious how the public will react. Latisse is a very popular product, getting huge traffic on beauty boards as people compare notes on how to solve their lash problems without makeup. It will be interesting to see what develops as the FDA and Allergan come to an agreement on how to present side-effect information fairly.

Long-term sufferers of insomnia who have not found lasting relief from such sleep aids as Ambien or Sonta should consider researching Rozerem, the only medication of its type approved in the treatment of sleeplessness.

Rozerem (ramelteon) is the first of a new class of insomnia drugs:

Long-term sufferers of insomnia who have not found lasting relief from such sleep aids as Ambien or Sonta should consider researching Rozerem, the only medication of its type approved in the treatment of sleeplessness.

Rozerem (ramelteon) is the first of a new class of insomnia drugs: melatonin receptor agonists. These are similar to the naturally-produced sleep hormone melatonin, which your body needs for healthy sleep cycles. Rozerem, manufactured by Takeda Industries North America, was approved by the FDA in July 2005 for the treatment of delayed-onset insomnia. It emerged against a backdrop of other classes of drugs to treat the condition — and it has some important differences.

Insomnia was historically treated with barbiturates, which were extremely strong and frighteningly addictive. In the Sixties, the benzodiazepines appeared. These drugs (such as Halcion) helped treat insomnia with a much lower rate of serious side effects and addiction, but still had moderate side effects such as dizziness and a hangover effect. In the Nineties, there emerged a new class of non-benzodiazepine sleep aids, including Sonata and Lunesta, which have safely helped many people combat insomnia. Still, as they target several broad areas of the brain that are involved in sleep, they still have considerable side effects on memory and clarity.

In 2005, Rozerem was approved as a treatment for insomnia. It is said to have a different, more precise mechanism than other sleep aids, with an ability to target the “master clock” of the human body, affecting the sleep-wake cycle without unduly interfering with nearby brain functions.

Because it is in a different class than Lunesta and Ambien, Rozerem may be an effective treatment for patients who have not found lasting results on these medications. If you have not reconsidered your insomnia treatment since this important new class of drugs appeared in 2005, it is worth researching these new developments, as they may cure your insomnia more effectively, or do so with fewer side effects.

Side effects: Common side effects on this medication are dizziness, drowsiness, and daytime sleepiness. Sometimes people using this drug sleep-walk or perform other actions in their sleep. More serious side effects involve hormonal changes such as missed periods, nipple discharge, or difficulty becoming pregnant. It is important to tell your doctor immediately if you experience depressed or suicidal thoughts while taking this medication. Finally, be aware of any symptoms of a very serious allergic reaction to Rozerem such as a rash or swelling. Call your doctor immediately if this occurs.

Cautions and contra-indications: Rozerem is not suitable for patients with liver disease. You should not take it if you are also taking fluvoxamine, rifampin, or certain antifungal antibiotics. You should advise your doctor if you suffer from any breathing disorders such as sleep apnea or chronic obstructive pulmonary disease. You should also tell your doctor if you have a history of mental illness, depression, or suicidal thinking. And of these factors might mean that you cannot take Rozerem, or that you might have an adjusted dose. Rozerem is a pregnancy category C drug, so it may be harmful to an unborn baby, or in breast milk. Finally, Rozerem may affect hormonal levels in men and women, with possible effects to the desire and fertility. Talk with your doctor about your reproductive plans if you are considering Rozerem.

As with any drug, please consult your doctor before taking.

Sometime back, Effect Measure posed a question many of us have pondered about direct-to-consumer (DTC) pharmaceutical commercials: What’s with the side-by-side bath tubs in the Cialis ads?

Here are some of the answers given in comments –

I read the following disturbing Q&A in Joe and Teresa Graedon’s People’s Pharmacy column this morning:

Q: I once worked for a pharmaceutical company that ordered a raw ingredient, diphen-hydramine, from China. I was a quality-assurance inspector and had to inspect incoming material.

That ingredient was trashy, with what looked like a lot of [...]]]>

I read the following disturbing Q&A in Joe and Teresa Graedon’s People’s Pharmacy column this morning:

Q: I once worked for a pharmaceutical company that ordered a raw ingredient, diphen-hydramine, from China. I was a quality-assurance inspector and had to inspect incoming material.

That ingredient was trashy, with what looked like a lot of floor sweepings and black blobs of something I could not identify. I placed all of that shipment on reject. I came in to work the next day and was told by the boss that he had authorized the release of that ingredient to be used in production!

When I left work later that day, I called the Food and Drug Administration and reported the whole thing. I called in the next day and quit my job.

A: We forwarded your shocking story to the FDA but have not received a response. Diphenhydramine is an antihistamine found in dozens of allergy medicines as well as sleep aids and nighttime pain pills.

Past experience with adulterated heparin and milk products, as well as pet food, suggests that Chinese ingredients require monitoring. A recent report from the Institute for Safe Medication Practices concludes, “It is increasingly clear that the nation is experiencing serious problems in ensuring that generic drugs are manufactured with adequate quality control.”

By now, we’ve all heard horrors stories about unsafe drugs, food, toys and other products imported from China. But I’m still amazed that the American public hasn’t been calling for the heads of government officials over this problem; it’s a basic responsibility of our government to keep its citizens safe.

In a report issued earlier this month, the Institute for Safe Medication Practices (ISMP) argues that one reason the public has not been more outraged is that the FDA has been less than forthcoming in sharing information. While the public knows that there have been recalls, the ISMP says, it doesn’t know just how serious the problem is.

As the ISMP summarizes the issue:

Concerns continue regarding serious problems our nation seems to be facing to ensure generic drugs are manufactured with adequate quality control.

In the first quarter of 2008, there were urgent recalls of most of the nation’s supply of one form of generic heparin and millions of fentanyl patches from several generic drug manufacturers. In the second quarter, about 50% of the nation’s supply of generic digoxin was recalled because over-strength tablets may have been manufactured and distributed. An additional generic digoxin recall was announced in March 2009.

In the third and fourth quarters of 2008, urgent recalls were announced for generic versions of morphine sulfate, propafenone, and isosorbide. All involved over- or under-strength tablets that could have significant health consequences. In addition, two NJ plants of the Actavis Group were closed and all products manufactured there were recalled due to manufacturing concerns. In December 2008, KV Pharmaceuticals’ plants were closed to resolve quality control problems.

The concern regarding the manufacture of generic drugs has received little public and official notice in part because FDA does not require disclosure of the size and impact of a product recall. To cite one example, neither Caraco Pharmaceutical Laboratories nor FDA would reveal how many digoxin tablets were involved in its March 31, 2009, recall notice.

Based on these findings, it seems apparent that FDA’s current system for inspecting plants, dealing with violations, and managing product recall notices requires systematic independent review.

While we’re not sure (yet) that an independent review of FDA practices is necessary — we may see significant change with the new leadership President Obama has put in place — we agree strongly that the FDA should share more information about the risks and dangers it is encountering in our drug supply.

That’s only fair to the public. It’s a step Obama’s FDA should take immediately.

When the topic of Americans buying drugs from Canadian pharmacies comes up, one company whose name is rarely mentioned is Google. That’s odd to me, since (1) Google is such a news magnet, and (2) without Google, far fewer Americans would be buying their prescription drugs from Canadian pharmacies.

Big Pharma despises Google for [...]]]>

When the topic of Americans buying drugs from Canadian pharmacies comes up, one company whose name is rarely mentioned is Google. That’s odd to me, since (1) Google is such a news magnet, and (2) without Google, far fewer Americans would be buying their prescription drugs from Canadian pharmacies.

Big Pharma despises Google for explicitly permitting licensed Canadian pharmacies to advertise to U.S. consumers through its AdWords network — a tacit endorsement of cross-border medication sales. For some time now, Big Pharma and its proxies have been waging a secret campaign to force Google to stop allowing Canadian pharmacies to advertise through AdWords.

Google’s AdWords program (working in partnership with PharmacyChecker.com) has been highly effective in screening out rogue pharmacies and not allowing them to use AdWords. You can rest assured that any Canadian pharmacy you see in a Google ad is a legitimate pharmacy licensed by the Canadian government.

But — and this truly is a rich irony — the FDA now says that Big Pharma itself is abusing AdWords.

Google and Canadian Drugs

First, some background. It would be easy enough for Google to say no to ads from Canadian pharmacies (it certainly doesn’t need the revenues). But instead, Google chooses to team with a well-respected verification authority, PharmacyChecker.com, to screen pharmacies to ensure that only those licensed by the Canadian government are allowed into the Google ad network.

Since Google’s CEO has campaigned for Democratic candidates, it’s not a stretch to conclude that the company is projecting a public-policy position on the issue of drug reimportation — although I’ve never seen a statement by the company on the issue. Either that, or it could simply be a nod to the Web’s libertarian tradition.

Whatever the case, Big Pharma doesn’t like what Google is doing, and they’re trying to stop it. In today’s pro-reimportation political climate, you might think this effort would be quixotic. However, you should never underestimate the power of Big Pharma money to influence public policy — and to turn the screws on other companies, even one as mighty as Google.

Fortunately, the Google-PharmacyChecker relationship seems solid — and the result, in terms of the quality of online pharmacy advertising on AdWords, speaks for itself.

Big Pharma’s AdWords Deceptions

The same can’t be said for Big Pharma’s own AdWords ads, however.

According to Search Engine Land:

The U.S. Food and Drug Administration (FDA) has sent letters to a number of pharmaceutical manufacturers to alert them that they were in violation of acceptable marketing practices in relation to their paid search marketing campaigns.

The basic gist of the letter is that when these pharmaceutical companies advertise on Google they are a.) not providing the risks associated with the drugs and b.) not including their “established name.”…

Hey, Big Pharma — maybe it’s time to stop worrying about Google’s Canadian pharmacy ads, and to start worrying about your own?

Nah, that makes too much sense.

Despite celebrity endorsements courtesy of Photoshop (above), and a real endorsement by eDrugSearch.com and others, Pfizer whistleblower Dr. Peter Rost came up short in his bid to become the next FDA commissioner. President Obama on Saturday announced the selection of Dr. Margaret Hamburg for the top food and [...]]]>

Despite celebrity endorsements courtesy of Photoshop (above), and a real endorsement by eDrugSearch.com and others, Pfizer whistleblower Dr. Peter Rost came up short in his bid to become the next FDA commissioner. President Obama on Saturday announced the selection of Dr. Margaret Hamburg for the top food and drug post.

We knew Peter was a longshot for the post, but what the heck — it was worth a shot.

The good news is that Dr. Hamburg will bring a passion for and history of reform to an agency that needs it desperately.

For Americans under 30, it might surprise you to know that the FDA has not always been a public laughingstock. In fact, in the 1970s, it earned a public confidence rating of 80 percent — among the highest of all government entities. That rating has now dropped to less than 40 percent, making it one of our least trusted federal agencies.

It’s not difficult to track this decline.

During the Reagan presidency, the FDA’s staff was slashed by 30 percent. It was cut even more in the ’90s, when Newt Gingrich led a pogrom against the agency, effectively arguing that private businesses could police themselves. This “starve the beast” mentality continued under George W. Bush. From 1994 to 2007, the agency staff was chopped from 9,167 to 7,856.

Ironically, the whole anti-FDA movement started with President Reagan’s claims that the agency was effectively “murdering” Americans by spending too long approving needed drugs.

Of course, cutting agency personnel by 30 percent doesn’t necessarily speed things along; it just spreads agency resources more thinly, so that more mistakes are made, the agency gets blamed, and more resources are cut to punish the agency as a result.

And so finally, the FDA reached a breaking point — and we’ve seen an across-the-board meltdown over the past few years, both with food safety and drug safety.

President Obama clearly wants to turn the ship around, back in the right direction. Here’s a brief video in which he outlines his plans for the FDA:

If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food [...]]]> The Day of New London, Conn., has a nice article on Dr. Peter Rost’s bid for FDA commissioner. Here’s an excerpt referencing our interview with Peter:

If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food and Drug Administration.

So guess who is actively seeking the FDA’s top post?…

Rost said he is looking for a shakeup of the FDA, including a reorienting of the agency’s priorities from serving the drug industry to helping American citizens.

”That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling (is) revised in a more timely manner,” Rost said in an interview this week with eDrugSearch. com, which endorsed his candidacy.

Some of Rost’s most controversial stances include his views on reimportation of drugs from Canada, which he approves, and his opposition to direct-to-consumer advertising.

”DTC advertising is not part of a ‘free market’ – it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for,” Rost said.

We have also been pleasantly surprised to see the groundswell [...]]]> It should come as no surprise to readers of this blog that we are delighted about the prospect of a new FDA commissioner in 2009 — one who we hope will put the interests of the people above those of large pharmaceutical companies.

We have also been pleasantly surprised to see the groundswell of public support for Pfizer whistleblower Dr. Peter Rost for the FDA’s top job. A clear industry outsider like Dr. Rost might seem a longshot to ultimately win the job — but then again, Obama was a longshot to win the presidency. And there are these three hopeful signs:

1. Dr. Rost is blowing away the competition in the voting at John Mack’s influential Pharma Marketing Blog. (Vote here.)

2. President-elect Obama’s chief of staff is a big fan of Dr. Rost.

3. Dr. Rost himself has jumped on the bandwagon, renaming his blog “Peter Rost for FDA Commissioner”!

Today, eDrugSearch.com officially endorses Peter Rost for FDA commissioner. We think he would bring the changes the agency so desperately needs.

On the occasion of our endorsement, Dr. Rost agreed to answer a few questions about how he would handle the commissioner’s job. He has some insightful comments on topics ranging from Canadian drugs to DTC advertising. Enjoy —

eDrugSearch.com: In the 1970s, the FDA had one of the highest public approval ratings among government agencies. Today, the agency’s reputation is a mess. What went wrong?

Dr. Rost: Same reason Wall Street’s reputation used to be great and is now a mess; they screwed up. The FDA is there to protect the public health, both by approving life-saving drugs and taking dangerous drugs off the market. They got too focused on approval and lost out on protecting the public against dangerous drugs (i.e. Vioxx); as a result we’ve had a number of scandals when the FDA has been perceived as being way behind the eightball.

eDrugSearch.com: What are the first three actions you would take as FDA commissioner, and why?

Dr. Rost: It is really impossible to answer without first having had a chance to evaluate the agency from the inside. In general terms, however, I’d like to reorient the FDA to focus on its primary customers . . . American citizens, instead of primarily serving the drug industry. That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling revised in a more timely manner. Both these objectives should be equally important.

I would also want to ensure that hundreds of unapproved drugs that are sold illegally as prescription drugs would be taken off the market, and that reimportation of drugs would become legal and regulated and appropriate safety measures taken to protect the public.

Finally, I’d want to bring the kind of internal and external accountability that normally exist within private corporations to a government agency and work for limitation of direct-to-consumer advertising, which is counter productive to efficient healthcare.

eDrugSearch.com: Are there concrete steps the FDA commissioner can take — directly or indirectly — to help reduce the cost of prescription drugs for American consumers? If so, what are these steps and how would they impact drug prices?

Dr. Rost: Support legalized and regulated reimportation of drugs, which would increase price pressure.

eDrugSearch.com: What is your view of the Wyeth v. Levine case? How do you believe the Supreme Court should rule and why?

Dr. Rost: My view is that no government agency, including the FDA, should be considered the equivalent of “God.” An FDA decision or lack of decision shouldn’t preempt a legal challenge and an FDA decision or lack of decision shouldn’t be used as a legal shield. The FDA doesn’t know everything, doesn’t have all information, only what it receives from drug companies and doctors . . . quite frankly, a decision in favor of preemption would be a disaster for American consumers.

eDrugSearch.com: What should the FDA do about direct-to-consumer drug advertising? Is there a role for consumer advertising of prescription medications — and if so, what should that role be?

Dr. Rost: I used to be in favor of DTC and a “free market” but a free market requires informed consumers. Most of them don’t have medical degrees; hence, most of them are not qualified to judge and make decisions based on DTC advertising and, hence, DTC advertising is not part of a “free market” — it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for. DTC advertising is not in the best interest of evidence-based healthcare or the American consumer.

eDrugSearch.com: Are there ways the FDA can leverage Health 2.0 and other technologies to do its job better?

Dr. Rost: Yes. We are still in the Stone Age when it comes to optimizing use of eHealth, sharing information and medical collaboration and education. Too big a topic to get into detail.

eDrugSearch.com: What would you do as FDA commissioner regarding Canadian drug reimportation?

Dr. Rost: I’m in favor of regulated and legalized reimportation with access to these drugs through regular brick and mortar pharmacies. Today we have a very dangerous system, the Wild West. We need to protect consumers from illegal and misbranded drugs sold by Internet pharmacies. The only way to do it is to legalize and regulate this trade.

eDrugSearch.com: President-elect Obama has been a vocal advocate of Canadian drug reimportation. Apparently in response, Big Pharma and its proxies have been waging a renewed battle against reimportation in the media. Specifically, opponents of reimportation make the case that the FDA lacks the necessary staff and other resources to effectively regulate drugs coming in from Canada. What do you think of this argument?

Dr. Rost: That’s BS, like most of what Big Pharma has been saying in respect to reimportation. In Europe this has been done for 20 years with no major staffing issues.

eDrugSearch.com: Opponents of drug reimportation also claim that drugs coming into the United States from Canada do not meet the same standards as the drugs dispensed to Canadian residents. What do you think of this argument? Can we trust the Canadian government’s licensing procedures to protect the safety of U.S. consumers? What should be the FDA’s role in this issue?

Dr. Rost: Untrue. We can trust both Canada and Europe, since they use drugs from the same manufacturers and have stringent approval procedures. In fact, drugs from these countries may be safer than U.S. drugs, since we have a completely fragmented, state-based system regulating drug trade and wholesalers with lots of entry points for counterfeit drugs. The FDA’s role should be the same as for any other drug, ensuring safety of the drug supply.

eDrugSearch.com: eDrugSearch.com is delighted to endorse you for FDA commissioner! Any final thoughts for our readers?

Dr. Rost: Well, if Obama really is looking for CHANGE what better way to do this than to appoint a candidate who has already shaken up the drug industry?

In the end, we need an FDA accountable to the public, ensuring not only availability of life-saving drugs but also better protecting us against dangerous drugs.

We’ve had enough of tainted advisory boards and people who scratch each others backs, I think I could bring in some fresh air and sunlight.

The FDA is never going to be perfect, but we can all agree that this is one government agency which could do a lot better. The American public deserves better and so do all the great FDA staffers. I don’t think FDA employees are the problem, I think the issue we’ve had is a lack of leadership at the top and we need to bring in someone who has the guts to do what it takes and the vision to know that nothing is ever impossible.