Lipitor U.S. Sales Tank 70% in 2012 vs 2011!

Lipitor U.S. Sales Tank 70% in 2012 vs 2011!

According to Drugs.com, Lipitor U.S. sales in Q2 of 2012 were only 30% of what they were in Q2 2011 ($579 million vs. $1,949 million, respectively (see chart below; Source: http://www.drugs.com/stats/lipitor).

Meanwhile, sales of Crestor (a competitor anti-cholesterol drug) increased only somewhat during the same period (see chart below; Source: http://www.drugs.com/stats/crestor).

I conclude that most of the loss of Lipitor sales was due to direct competition from generic versions of Lipitor now currently available, which is further proof that Pfizer's "innovative" attempts to stem the generic Lipitor tide has failed (see also "Pfizer Throws In the Lipitor Marketing Towel").

Does Generic Competition Stifle Branded Pharma Innovation?

Does Generic Competition Stifle Branded Pharma Innovation?

Sure, use of generic drugs saves payers -- U.S. Gov't, insurances companies, and patients -- money. But does generic competition harm the innovation of new and improved drugs?

According to a report published by the Generic Pharmaceutical Association (GPhA), the answer is no. Let's look at some of the data.

First, the GPha claims that generic prescription drugs in the U.S. saved about $193 billion in 2011 alone and over $1 TRILLION in the last 10 years (see "Generic Savings in U.S." for a copy of the report and top figure in the infographic shown here; click here for a full-size view of the infographic).

Given that there is just one prescription drug pie to share, that must mean that the branded pharma industry's slice has decreased somewhat proportionately, even though the whole pie may has grown over the years (by what %?).

But GPha does not discuss THAT in its report. Instead, it focuses on "innovation" and the defense of the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman), which had the dual objectives of incentivizing the development of new brand drugs (the patent term restoration part) and facilitating the approval of generics to lower consumer costs (the drug price competition part).

The Hatch-Waxman Act has recently come under attack as being too favorable to the generic drug industry. An article in the November 2011 issue of Health Affairs, for example, argued that "generic usage has increased so markedly that the incentive to develop new drugs has been harmed" (said GPhA). From the abstract of that article:

"Generic drug usage and challenges to brand-name drugs’ patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation" (see "Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act").

As evidence that this is not true, GPha presented new drug approval data from the FDA. The data it presented was similar to the middle chart in the infographic shown here. The GPhA chart only went back 10 years to 2002, whereas the chart shown here goes back to 1994. Although the trend in new drug approvals by the FDA is downward between 1994 and 2011, in recent years (ie, since about 2002), it is trending upward.

Drug approvals by FDA may not be the best indicator of innovation, however. Consequently, I added to the infographic another chart from the FDA that also shows the number of NDAs (new drug applications) filed with the FDA in the last 10 years.

I notice that the number of approvals seems to be directly related to the number of NDAs filed. The FDA often argues that it is not its fault if less drugs are approved in any given year -- it's the fault of fewer NDAs being filed (ie, lack of innovation by the drug industry).

In any case, the GPhA argument seems to have merit. So much so that the branded drug industry -- i.e., its trade association, PhRMA -- chose not to dispute the evidence, but made lemonade from GPhA's lemons.

PhRMA pats itself on the back, saying that "without the development of new medicines by innovator companies, there would be neither the new medicines essential to progress against diseases nor generic copies." Here's more from PhRMA on that:

"[GPhA's report] documents one of the many benefits achieved by new medicines developed by biopharmaceutical research companies. Cost savings attributable to generic drugs represent one stage of the prescription drug lifecycle. Such savings are possible because innovator biopharmaceutical research companies – the most research-intensive sector in the U.S. economy – produce medical advances through pioneering scientific work and long-term, expensive investments. Over time, these innovative new medicines lead to generic copies that patients use at low cost for many years" (see "PhRMA Statement on Prescription Drug Costs").

What do you think?

Does generic drug competition harm the innovation of new drugs?
	Yes
	No

Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?

Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?

"Coupons for drug co-payments are illegal and drive up long-term health-care costs for all, a consumer group and four trade-union health-insurance plans said Wednesday in announcing lawsuits against eight pharmaceutical companies," reported the Philadelphia Inquirer (see "Trade union health plans sue 8 pharma companies over drug coupons").

The eight drug companies being sued are:

1. Abbott Laboratories
2. Amgen
3. AstraZeneca
4. Bristol-Myers Squibb 
5. GlaxoSmithKline
6. Merck & Co.
7. Novartis
8. Pfizer

The lawsuits claim that although coupons reduce the consumer’s out-of-pocket cost, the health insurer still pays the previously negotiated price to the drug company. "With no savings from generics, health plans will need to charge patients more to keep up with rising costs, the lawsuits say."

That was precisely my criticism of Pfizer's attempt to compete with generic versions of Lipitor by offering consumers coupons that lowered the co-pay to $4:

"Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased," I said. "But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!" (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

In a comment submitted to the Inquirer, Wells Wilkinson, JD., Director, Prescription Access Litigation Project, said:

"If a drug is a patient’s only option, and it has no real alternative, then we applaud when companies like Pfizer help patient in need afford their medications.

"But copay coupons are not aimed at patients in need, they are marketing tools that target people with insurance. Distributed for drug companies by doctors and pharmacists alike, they can be coupled with tv ads that promote an expensive drug. For instance, Lipitor is competing with other statins that cost one-fifth to one tenth as much. In fact some statins (like lovastatin, pravastatin) are so inexpensive you can get them for $4 without any insurance at all. Does it help the consumer in the long run to trick them into using a coupon, and passing on $120 in costs to their health plan, when they could buy a low-cost statin that is just as effective for $4 with no cost to their employer or health plan?

"Consumers need to see that there are real costs to using coupons – costs that drive up their premiums and their employers costs for health care. Forgoing copay coupons and using lower cost drug also helps save funds that they may need later, or that their coworkers need for the really expensive drugs with no alternatives.

As more and more drugs lose their patent protection and become available at competitive prices, consumers should use these first, and take advantage of market competition to keep our health care costs down."

It should be noted that federal Medicare and Medicaid programs prohibit the use of coupons because they can hurt the programs, which have to pay for higher-cost drugs that the coupons promote.

Pfizer had nothing to say except "While many health plans have raised their co-pays and/or are encouraging switching to generic medications to achieve cost-savings, these treatments may not be appropriate for all patients."

The drug industry continues to claim that generics are "different" than brand name drugs and therefore "may not be appropriate for all patients." It's also an argument the industry makes against "biosimilars" or follow-on biologics. What do you think?

Are generic versions of non-biologic drugs such as Lipitor appropriate for patients who were previously prescribed the brand name drug?
	Yes, always
	Yes, in most cases
	No, never
	I have no idea

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer is the world's most "innovative" drug company, not in terms of developing new drugs to treat, for example, high cholesterol -- which it failed at spectacularly (see "Why Pfizer Flopped"), but at keeping old drugs on the market beyond their patent expiration date and competing with generic drug companies. I am referring, of course, to its efforts to keep Lipitor on the market competing with generic versions after Lipitor's Nov 30, 2011, expiry date. Lipitor Won't Go Gentle Into that Good Generic Night! as I commented on in a previous Pharma Marketing Blog post (see poem here).

The first phase of Pfizer's innovative "Save Lipitor" plan was an unprecedented level of direct-to-consumer (DTC) marketing of Lipitor. In 2010, Pfizer was the biggest DTC spender -- it's $967.5 million DTC budget for that year was more than double the DTC spend of its closest rival, Eli Lilly (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"). Of that amount, approximately $251 million was spent to advertise Lipitor to consumers. An additional $410 million was spend promoting Lipitor to physicians ($1500 of which went to "wining and dining" my physician; see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") and supplying free samples (see chart below).

Just a week or so ago, I learned that Pfizer reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- that would compel many drugstores to block prescriptions for a generic version of Lipitor (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

Now, according to this WSJ article, Pfizer is planning to sell Lipitor at generic prices directly to patients. "If successful," says the WSJ, "the risky move could rewrite the industry's playbook for selling medicines." So, THAT's the "Playbook" Pfizer is writing (see back story on that here).

All this sounds like good news for patients like me who have been advised by their physicians to switch to Lipitor because "it's a second generation statin that will be available in generic form." But wait! First of all, my drug plan has to be in cahoots with Pfizer to offer it to me at the generic price (actually, to request pharmacies and PBMs it works with to NOT substitute a true generic version of Lipitor when my doc writes "Lipitor" on the script).

But the savings will not be passed on to employers who will pay higher rates to keep Lipitor on their plans' formularies. What are employers likely to do in that case? They'll pass the added expense on to their employees by requiring them to contribute more to their health coverage!

Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

"I'm mad as hell and I'm not going to take this any more!"

I love that line from the 1976 movie Network. The whole scene in which fictional news anchor Howard Beale goes on a "rant" is even more appropriate today. You can watch the YouTube version at the end of this post.

Today, however, I'm mad as hell at Pfizer in particular and plan to boycott its products or even "occupy" its corporate headquarters in NYC -- or maybe symbolically "occupy" it here on the Social Media Network and urge my readers -- much as Beale urged his fictional UBS Evening News viewers -- to at least stand up and say to Pfizer "I'm mad as hell and I'm not going to take this any more!"

Why am I mad as hell at Pfizer? I just read a story in the New York Times that explains how Pfizer has reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- the results of which is that "many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins" (see "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor").

That's why I just issued my Howard Beale "call to action" via a Twitter post: "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor: ow.ly/7sEkz @pfizer_news: I'm mad as hell!"

Recall that I wrote a recent spoof about Pfizer's plans to keep Lipitor alive in the market (see "Lipitor Won't Go Gentle Into that Good Generic Night"). Little did I realize, however, that the PBM-Pfizer deal would result in drug stores refusing to substitute the generic version when filling prescriptions for Lipitor or to give patients Lipitor even when the prescription is for a generic version. The reason is that because of the rebates Pfizer offers to the PBMs, the co-pay for Lipitor scripts will be lower than the amount the patient would have to pay for the generic! The PBMs pocket the profits, wheres the payers (taxpayers like me and employers like me) get stiffed with the higher bill for Lipitor scripts.

"Raymond F. Kerins, a Pfizer vice president and spokesman, issued a statement saying Pfizer was committed to supporting patients’ continued access to Lipitor. He declined to answer further questions Friday afternoon," reported the NY Times. Typical of Kerins, who does not like to reveal much (see "Pfizer, Show Us Your Social Media 'Playbook'").

Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased. But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!

I also have a personal stake in this because my Doctor -- who has received payments from Pfizer in 2010 (see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") -- wants me to switch from a generic of Pravachol to brandname Lipitor to control my high cholesterol level. Just on the basis of the above story and the fact that my doctor was wined and dined by Pfizer, I feel that I should boycott Lipitor until I can truly get a generic version.

Am I putting my health at risk by refusing Lipitor? I don't think so. When I think how mad and helpless I would feel while taking Lipitor because of this PBM-Pfizer deal, my blood pressure would rise and I would be at greater rise of having a heart attack. I wouldn't, however, be at a greater risk of committing suicide as Howard Beale did in the movie Network, unless, of course, I was also taking Chantix!

I urge you to post a note to Pfizer on Twitter (@pfizer_news) and say that you oppose its PBM kickback plan and that you are now "occupying" Pfizer by sending out daily tweets with a similar message until Pfizer backs down. Use the hash tag #OccupyPFE (PFE is Pfizer's stock symbol -- a fitting acronym considering Pfizer's deal will mainly benefit its investors).

Here's the "mad as hell" scene from Network:

Lipitor Won't Go Gentle Into that Good Generic Night

Lipitor Won't Go Gentle Into that Good Generic Night

Today's Wall Street Journal reports that "Pfizer Inc. isn't rolling over and conceding the market for its cholesterol-lowering drug Lipitor after the blockbuster brand loses its U.S. monopoly at the end of the month" (read the article here). Pfizer has an aggressive co-pay card/PBM discount plan that it hopes will allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched.

This has prompted me to man-handle Dylan Thomas's famous poem as an ode to Lipitor and its fight against patent expiry:

Do not go gentle into that good generic night,
Patent expiry should burn and rave at close of day;
Rage, rage against the dying of the innovator's right.

Though wise marketers at patent end know generic is right,
Because their words had forked no lightning their Rx brands
Do not go gentle into that good generic night.

Good Rx brands, the last wave by, crying how bright
Their frail market share might have danced in a greener pasture,
Rage, rage against the dying of the innovator's right.

Wild marketers who caught and sang cholesterol numbers in flight,
Learned, too late, Lipitor's fate, they grieve it on its way,
Do not go gentle into that good generic night.

Grave Rx brands, near death, that see with blinding sight
Off-patent drugs could blaze like meteors and be gay,
Rage, rage against the dying of the innovator's right.

And you, my Lipitor, there on the sad market height,
Curse, bless, your loyal patients now with your fierce tears, I pray.
Do not go gentle into that good generic night.
Rage, rage against the dying of the innovator's right.

Brand(o) Pharma Makes Offer Generic Companies Can't Refuse!

Brand(o) Pharma Makes Offer Generic Companies Can't Refuse!

According to the  Federal Trade Commission (FTC), some brand pharmaceutical companies are imitating Marlon Brando's portrayal of the Godfather: They are making offers to potential competitors that they hope can't be refused.

 As reported today in the New York Times (see here) "some drug makers are using an indirect method to delay competition from low-cost generic products by promising not to introduce their own generic versions if a potential competitor delays its entry into the market.

“Instead of saying, ‘Here’s $200 million, go away,’ they’re saying they could penalize them $200 million, but they won’t, so go away,” said Jon Leibowitz, chairman of the FTC.

The FTC issued a final report (attached to this post) on authorized generic drugs that concludes when pharmaceutical companies introduce an authorized generic version of their brand-name drug, it can reduce both retail and wholesale drug prices. The report also found that authorized generics have a substantial effect on the revenues of competing generic firms. Over the longer term, by lowering expected profits for generic competitors, the introduction of an authorized generic could affect a generic drug company’s decision to challenge patents on branded drug products with low sales. However, the report concludes that in spite of this, patent challenges by generic competitors remain robust.

Finally, the report finds that some brand companies may have used agreements not to launch an authorized generic as a way to compensate would-be generic competitors for delaying entry into the market.

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

"The drug industry is floundering in its ability to provide the public with many of the basic medicines that are absolutely required for the treatment of a host of diseases," said Paul Torrence, former Section Chief, MIH, in a recent OpEd piece (see here).

Torrence called for a National Institute of People's Medicine that "would ensure that drug inventories are always well stocked. It would additionally be the driver and funder of cutting-edge drug discovery and development for antibiotics. Working through out-sourcing and contract mechanisms, the NIPM could rejuvenate research funds-deprived academics and mobilize small pharma to manufacture requisite medicines.

According to the FDA, "In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration, 132 of which involved sterile injectable drugs. In 2011, FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding" (see Drug Shortage FAQs).

Various causes of the current crisis have been suggested: (1) manufacturing quality issues, (2) market manipulation (eg, price gouging), (3) mergers of pharma companies who cut out low profit margin drug lines, and (4) lack of profits to be made from certain generic drugs.

Whatever the cause, the American Society of Health-System Pharmacists (ASHP) calls the current drug shortage in the US a "crisis" (view this video -- interview at 36 mins, 30 seconds).

The last time we heard of a crisis affecting the entire nation was the 2008 "financial" crisis. That was met with swift action by the US government, which intervened in the market to help ward off the crisis in lending (ie, shortage of money).

If the government can address a national money shortage crisis, why can't it also address a national drug shortage crisis?

Can the United States Ensure an Adequate Supply of Critical Medications?

That's the question ASHP asked in an FDLI Food & Drug Policy Forum article (attached to above cited post), the introduction to which states:

"This dramatic rise in the extent, duration and severity of shortages is occurring in an environment that is characterized by a near absence of communication between drug manufacturers and the Food and Drug Administration (FDA). This lack of transparency is a significant barrier to efforts to address drug shortages, and it represents a real and growing danger to patient safety. FDA has worked diligently to address this issue, but this work is hampered by the agency’s inability to require reporting of information that could be instrumental in minimizing the impact of a shortage or averting it all together."

More resources:

• Cancer drug shortages getting worse, FDA says (USA Today)


• Cancer Drug Shortage: Why Is This Not Front-Page News? (Health Beat Blog)

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Double-Dip Viagra Patent Means No Recession for Pfizer

Double-Dip Viagra Patent Means No Recession for Pfizer

Pfizer proves once again that it's not all about the science when it comes to "innovation." It's also nice to hedge your bets by winning patent infringement cases to keep marketing exclusivity for as long as possible.

Yesterday, for example, Pfizer prevailed in its Viagra patent infringement action against Teva Pharmaceuticals USA, Inc. in the United States District Court for the Eastern District of Virginia.

It wasn't, however, your typical patent infringement case. Pfizer actually has TWO patents for Viagra. One patent, which expires in March 2012, covers sildenafil (Viagra's active ingredient) for use in treating heart-related conditions such as high blood pressure. During the clinical trials, however, Pfizer discovered that the drug can improve erectile dysfunction (ED), the condition for which it eventually received marketing approval from the FDA.

In 2002, however, Pfizer double-dipped into the US patent office and received a NEW patent for Viagra to treat erectile dysfunction. It was THIS patent, which expires in October 2019, that was upheld in court yesterday.

According to a Wall Street Journal article (here), "In siding with Pfizer, Judge Smith wrote that in the early to mid-'90s, a person trained in the art of drug development 'would have no expectation that oral administration of such compounds would be successful in treating ED, and thus such method was not obvious to try.'"

Hmmmm... But Pfizer filed for the ED patent in 2002, when it obviously KNEW full well that oral administration of Viagra would be successful in treating ED. Pfizer obviously also knew that it would be successful in the 90s because it stopped the cardiovascular trials and pursued the NDA for ED.

In court, Pfizer essentially argued that it was not technologically savvy enough to know that sildenafil could treat ED while at the same time it pursued FDA approval PRECISELY for that condition. Talk about having your cake and eating it too!

If the court decision is not challenged on appeal, Pfizer will enjoy "continued market exclusivity" that will boost earnings by "roughly 3% annually between 2013 and 2018, a period in which profit otherwise would be under pressure due to the expected loss of exclusivity later this year for Pfizer's top-selling Lipitor cholesterol pill."

It's good to be the Pfizer! Pfizer shares were up 2.2% to $18.25 in early afternoon trading Monday on the New York Stock Exchange.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Branded Pharma Wages War Against Generic and OTC Medicines: COLCRYS vs. colchicine Case Study

Branded Pharma Wages War Against Generic and OTC Medicines: COLCRYS vs. colchicine Case Study

The drug industry often claims that it is facing an unprecedented "patent cliff" -- ie, a point when many branded drugs lose their patents and generic drug versions enter the market to compete.

To forestall falling off that cliff, many pharmaceutical companies engage in practices akin to war -- at least war as it practiced today -- using bribes, technology, and legal skirmishes, all aimed at generic drug manufacturers (see, for example, "Pharma's 'pay-for-delay' deals leave American consumers footing the bill" and "Sanofi Pays Doctors to Dis Generic Version of Lovenox").

All these tactics involve protecting innovative drugs first developed and brought to market by brand drug companies. When these drugs go off patent, generic drug companies can seek FDA approval to bring "equivalent" no-name, cheaper versions of the drug to market, and thus increase competition.

Occasionally, however, a drug company invades OTC (over-the-counter) drug company turf by obtaining new patents and exclusive marketing approval for a drug that once was OTC. I've posted about this before; ie, regarding LOVAZA, an FDA-approved version of OTC Omega-3 Fatty Acid Supplements (see "Drug Industry Innovation: GSK's LOVAZA Vs. OTC Omega-3 Fatty Acid Supplements" and "Proof That Pharma Marketing Works: Lovaza sold more than $1 B in 2010!").

Another case that recently came to my attention was COLCRYS, an FDA-approved version of colchicine, which has been available as a unbranded medicine prescribed by physicians or perhaps even "over-the-counter" without a prescription for ages -- and sold cheaply. According to Wikipedia, colchicum extract was first described as a treatment for gout in De Materia Medica by Pedanius Dioscorides in the first century.

Ever since URL Pharma got FDA approval for marketing COLCRYS for treatment of gout, it has been difficult for gout sufferers to get "generic" colchicine. This may be due to FDA's and URL Pharma's coordinated effort to wage war against colchicine.

URL Pharma's War against "generic" colchicine was recently in the news when it was discovered that its attorneys sent threatening letters to doctors who were prescribing "generic" colchicine. Some doctors had advocated use of a cheaper version of the drug, whose active ingredient is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions (see "Pharma Company Sends Letters to Docs Who Criticized Drug Online").

Not only doctors are complaining about this, so are patients. I recently received this letter from a reader:

"I have to write this in the dark and I can’t send it to you via the internet as the FDA, the drug companies, and the US Patent Office have me under surveillance.

"This colchicine thing is just the beginning of wiping out low price and low profit generic drugs. Preparation H could be next!

"How is it that – as you can see from my CVS receipt in January, the cost for 60 colchicine pills (one month’s supply) was $27.80 - $8 paid by me and $19.80 paid by my Part D Medicare insurance. This has been the cost ballpark for the 10 years or so that I have been taking colchicine. (My copay under Part D is 20%, so I should have paid $5.56, but I have an $8.00 minimum copay).

"But then something happened, and all of a sudden, colchicine became a “new” super drug, even though it’s been around since the days of the Roman Empire. It is now called Colcrys, and you can see from my May receipt that my 20% copayment under Part D was $51.43, meaning that the full price is now $257.15. Funny thing though – the Medication Guide that comes with Colcrys says that it is colchicine. Hmmm? But I don’t need Colcrys – I’ll take the generic colchicine – sorry, there is no generic – this is a new drug with the common name colchicine and when your doctor prescribes colchicine, this is what you will get whether you like it or not – what you were taking before is not recognized by the FDA and is not allowed to be prescribed and sold.

"What? It worked just fine, and it was really cheap. Can I get it over the counter, like fish oil or flax seed with chick pea cream sauce? Wouldn’t it be OK over the counter like all those other health junk pills? No? Why not?

"Did the FDA test and fail the original colchicine for some reason? Did the patent office actually issue a patent to AR Scientific for colchicine in direct conflict with the doctrine of prior art? (like giving me a patent for the invention of the wheel – there is no patent for wheels just like there was no patent for colchicine, so I think I’ll apply for a wheel patent and talk to General Motors about royalties.)

"What say you and your friends who monitor the drug industry about this event? Speaking of fish oil!

"From Tony – the leader of gout sufferers of America – we have enough pain as it is!"

What does URL Pharma have to say about this? In a statement title "COLCRYS® VS. UNAPPROVED COLCHICINE," URL Pharma says, among other things:

"Unapproved colchicine products are sometimes incorrectly referred to as 'generic' colchicine. The term 'generic' drug means a drug that has been approved by FDA. In reality, there are no generic colchicine tablets."

So, there is no colchicine product that is approved by FDA as a "generic." OK, you say "generic," I say "over-the-counter." This is really semantics because the only REAL difference between OTC and branded colchicine is dosage form: FDA claims that COLCRYS is safer than colchicine primarily because it is a lower-dosage form and that "patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose:"

"FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose." [See this Safety Alert.]

You say "COLCRYS" and I say "colchicine"
You say "LOVAZA" I say "Omega-3 Fatty Acid"
"COLCRYS" "colchicine", "LOVAZA" "Omega-3 Fatty Acid"
Let's call the whole thing off

Oh, if we call the whole thing off
Then we must part and
Oh, if we ever part
That would save me MONEY!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Sanofi's "Strategic Use" (ie, Bribery) of "Third Parties" (ie, Physicians) to Influence the FDA

Sanofi's "Strategic Use" (ie, Bribery) of "Third Parties" (ie, Physicians) to Influence the FDA

In a report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA," the Senate Finance Committee said Sanofi SA "contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval" of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.

According a WSJ article (see "Sanofi Pays Doctors to Dis Generic Version of Lovenox"), "between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000" to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine (see "Duke medical researcher named in Senate report").

Dr. Tapson and the North American Thrombosis Foundation wrote letters to the FDA that claimed generic versions of the anti-clotting medication may not be as safe as the brand-name drug. Nowhere in these letters did Tapson or the Foundation disclose financial connection to Sanofi.

In an internal email, a Sanofi public-relations representative characterized the Society of Hospital Medicine letter as a "key accomplishment."

"If we were writing the FDA now," said Larry Wellikson, society's director, "we would be very clear about our relationship with any partner, including financial support."

DUH!

The End is Nigh! Judgment Day For Low Cost Generic Meds

The End is Nigh! Judgment Day For Low Cost Generic Meds

Some people think "Judgment Day" will come tomorrow, May 21, 2011, at 2 a.m. Eastern Daylight Time at which time will begin the "rapture" where "all the graves will be opened and all of the dead bodies will come out" and only the true believers will be saved.

I don't believe in that particular fantasy, but I do believe the end is near for so-called low cost generic drugs.

Several recent signs suggest that the stars are aligned against low cost generic drugs. Here's my summary of these signs.

For quite some time we've heard about "Big Pharma’s Record Drug Shortages" (see "The nation is facing an unprecedented drug shortage" and "What’s Behind Big Pharma’s Record Drug Shortages?"). Shortages might be caused by "too many mergers and acquisitions" that have reduced the number of suppliers.

Those stories put the blame on "Big Pharma," by which they mean brand name drug manufacturers. However, lost in the copy is the FACT that "almost all the shortages are generic drugs."

The second sign was reported by Jim Edwards over at bnet in his post "4 Pharma CEOs Admit They Jack Up Drug Prices for the Hell of It."

Edwards quotes David Snow, chief executive officer at Medco Health Solutions: “As their branded drugs approach the patent cliff, there has always been the tendency to see increased pricing toward the end, just to get the last dollar out of every drug before they lose brand protection."

Yet an NPR article titled "Big Pharma's Golden Age Leads To Generics Windfall" suggests the "wave" of drugs going generic "can save consumers plenty of dough."

That would be true if generic drug companies as well as brand drug companies were not jacking up prices "for the hell of it." Actually, prices are jacked up because there is a shortage, which can be artificially produced if there is a drug industry consolidation, which there seems to be in both the generic and brand name industries.

I've heard that the price of generics has NEVER been as low as some people believe even in times where there were no shortages. Actually, the prices of some generics can be as much as 80% of the equivalent brand name drug. Why is that? I mean generic drug companies have practically NO marketing budgets, which have been blamed for high brand name drug prices by pharma critics. You'd think that without the marketing and associated overhead expenses, generic drugs would be dirt cheap!

The fact is, "three-quarters of prescriptions these days are filled with a generic," points out NPR. "And the proportion keeps climbing." That means that generic drug companies have almost "cornered the market" (for small molecule drugs) and can charge what that market will bear (in the U.S., that is, where there are no price controls).

And soon the generic drug industry will "corner" the biologic drug market as well.

"Should the market develop according to plan," notes a WSJ article, "copies of these complex drugs [biologics] alone could make up around 50% of the expected $10 billion biosimilars market by 2016, according to data compiled by Capgemini Consulting" (see "Generics Companies Weigh In on Biological Drugs").

As biologics vie for the market to replace small-molecule pills, the situation will even be worse. As a commenter to the NPR article stated "Makers of brand-name biologics are spending big money to delay biosimilars coming onto the market, so even tho biologics like Enbrel, that goes off patent next year -- without the availability of a “biosimilar" – the cost of Enbrel will still be $1,500 a month."

The generics rapture is upon us! Save yourself!