What Does Weight Neutral Look Like?

Jim Edwards at BNET Pharma has another email from the ongoing Astra-Zeneca Seroquel saga.  This one outlining how the spin was put on weight gain associated with the drug.

Having had experience with drugs where patients experience weight gain, however not any of the antipsychotics in the news, I have been exposed to the concepts of "significant weight gain" and "weight neutral."  First, significant weight gain is any gain of weight that is plus or minus seven pounds; therefore if the patient stays within that 14 pound limit, they have not experienced a significant weight change.

There is then a statistical tool marketing can use called a scatter gram which will show that the majority of the patients are on the line.  Yes, some patients may have gained more weight and some patients may have lost more weight; however if the majority of them can be plotted along the line, you have a "weight neutral" profile.

Here's the visual:

HPV Vaccine Should Be Given To Girls and Boys

Cost-effectiveness is a concept we need to embrace in this country to help decrease spending and, in particular, decrease the evergreening of products or the approval of the same drug over and over again.  A new study has been released from the Harvard School of Public Health (HSPH) that says that it is not a good idea to provide a universal recommendation to vaccinate boys with the HPV vaccine because it is unlikely to provide comparatively good value for resources, in comparison to vaccinating young girls.

There is a lot of hypothesis in this article, which you can read here at PharmaLive.  The issue I have with this analysis is that we are talking about a sexually transmitted disease.  Yes, the long-term benefit of getting the vaccine is the prevention of cervical cancer; however, HPV would not be present, more times than not, without it being sexually transmitted.

We are placing the burden of prevention on one group in our society.  Young boys are carriers; however, it is the young girls who will have to expose themselves to potential adverse events or side effects.  We teach our children to be responsible and have safe sex.  Why not put weight behind it? 

The cost-effectiveness argument affects what insurance covers.  Therefore, even if you choose to vaccinate your son, your insurance may not cover it.  Don't allow this to become another oral contraceptive fiasco where for decades women have been suffering the side effects of having to take hormones daily.

When making recommendations about medications that are not common and who should receive them, thought needs to go into it besides just the dollar amount. 

Off-Label Use and Creating a Profit Incentive

Allergan’s off-label suit claiming that the off-label drug promotion ban violates the First Amendment right to free speech demonstrates one of the more misguided views in our industry. Jim Edwards does a phenomenal job of dissecting why Allergan might be taking this approach.

An FDA-approved indication shows that expensive clinical trials have been done and the promotional materials have been approved for distribution. This is the blessing a company receives when the FDA approves a drug for a specific indication.

The irony here, of course, is when you look at the case of Lucentis. As you remember, Lucentis is approved for wet macular degeneration in the eye and according to CMS, it can now be billed for roughly $2000/injection. Genentech also markets the drug Avastin , which for years had been used off-label for wet macular degeneration. CMS has just now released coding for the smaller dosing of Avastin and the physician will receive $7.20 per eye, which is less than the cost of the eye-sized dose the doctor purchases at $30 - $50 per injection.

For years, doctors had used a drug for off-label use, and the company began to restrict its inventory because of the clinical trials they were conducting in another drug for that specific indication. Now, after expensive clinical trials are done, the on-label drug creates a profit incentive for the physician using it and also creates waste for Medicare. Conversely, the drug that had been working off-label for years now creates a loss for the physician who uses it, but would be more cost effective for Medicare.

In light of Allergan’s suit, which is confusing because Commercial speech is not protected by the First Amendment, and the blowback from the industry critics regarding the pricing of Lucentis and Avastin, it seems that there is a lack of consistency between the FDA, OIG, and CMS. If Genentech had been allowed to promote Avastin for wet macular degeneration, would there have been any need for further clinical trials to prove efficacy and safety for a “different product?” And how did physicians profit from the off-label use during that time? Allergan brings to light a practice that is occurring all too frequently in terms of off-label use; it’s not just safety that needs to be looked at though, it is also the pricing and incentive for profits that the off-label use is creating.

Please Visit Our Friends

We have finally gotten our Sites to See list up, and we encourage you to visit others whose work we admire.  Today we want to highlight three.

First, the irascible PharmaGossip, who has been around for a very long time, and knows and tells all with such a sense of humor.  Because he is from the UK, you will not only get a different perspective, you will also learn more than just our industry.

PharmaConduct.org is by a formally trained analytical chemist who helps clients mitigate technology related risks.  Right now, he has a couple of interesting surveys up about Pfizer-Wyeth and who will stay and who will go.

And just for fun, as if you don't see enough marketing materials, check out Medical Brochures.

Compounding Tamiflu for Children

Due to the short supply of the liquid childen's version of the anti-influenza drug Tamiflu, pharmacists are making their own children’s version by mixing cherry syrup with the contents of the Tamiflu capsules.

But not just any cherry syrup. The prescribing information for Tamiflu lists cherry syrup made by the Humco Holding Group — a mixture of sugar, purified water, artificial cherry flavoring and some other common ingredients — as one of the approved liquids to mix with the medicine.

Humco has been scrambling to keep up with demand.

The company typically sells about 50,000 pint-size bottles of the syrup each year. But with the spread of pandemic H1N1 influenza, also known as swine flu, Humco shipped 100,000 bottles in September alone. In October it is planning to make 400,000 bottles.

The liquid version of Tamiflu is scarce because Roche, the manufacturer of the drug, is concentrating on making the capsules used by adults and older children, which it says is a quicker way to increase world supplies. The same production capacity needed to produce a liquid treatment for one person can be used to make capsules for more than 10 people, Roche says.

But Tamiflu’s label has instructions for pharmacists to make a liquid version themselves.

This practice, known as compounding, evokes “the origins of pharmacy,” said Leanne Trela, director of retail clinical services at Walgreens, the big pharmacy chain. But with mass-manufactured pills now the norm, she said, compounding is used mainly for special needs like adapting adult medicines for children.

Besides Humco’s cherry syrup, the Tamiflu label says that Ora-Sweet SF, a sugar-free syrup, can be used. Other syrups could conceivably be used as well, but the label notes that others have not been studied.

Syrups used for compounding are considered foods by the Food and Drug Administration. Approval is not needed from the agency before such products can be marketed. But certain manufacturing processes must be followed, and factories are subject to inspection.

Source

Google Wave - The Way We Will Communicate

If your company is not looking into this or something like it, you will be at a disadvantage. 

Autism: An Unmet Medical Need - So Where's the Funding?

Beautifully done; speaks for itself...




Source: http://www.youtube.com/
"I Am Autism," a video by Academy Award-nominated director Alfonso Cuarón and Grammy-nominated songwriter/producer Billy Mann, debuted on September 22, 2009 at Autism Speaks' Second Annual United Nations World Focus on Autism at the United Natons

Corporate Officers Do Not Have Clean Hands

We try not to get too "legalese" around here; however, with the Pfizer settlement and the seemingly Teflon executives that exist in our industry, we thought this was important.

Strict liability, or, as it is also referred to as the "Park Doctrine", is an old tactic that appears to be coming back in vogue. Strict liability allows the government to seek a misdemeanor conviction against company officials, such as the CEO, VPs, Scientific Officer, General Counsel, for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) - even if the higher-up was unaware of the violation. The reason being is the company official was in a position of authority to prevent or correct the violation "of intent to defraud or mislead felonies under the FDCA."


So what does this mean? Well, in the recent cases of Pfizer or Lilly, where the unethical behavior was shown to go high in the organization, will we be seeing the application of the Park Doctrine?

Some history - in 1984, the U.S. Sentencing Commission created categories of offense behavior and offender characteristics for purposes of achieving consistent sentencing. Remember this.

May, 2007, Purdue Frederick Company pled guilty to felony charges for misbranding OxyContin with the intent to defraud or mislead. The allegation was that Purdue claimed OxyContin was less addictive, less subject to abuse and less likely to cause withdrawal symptoms. Three current and former executives pled guilty to misdemeanor charges as "responsible for corporate executives" under Park.

Medical device company - Norian's four corporate officers pled guilty. The government indicted Synthes, a wholly-owned subsidiary of Norian, for off-label promotion of bone-filler Norian XR in spinal procedures. The company allegedly conducted clinical trials of a significant risk device without an approved Investigational Device Exemption.

To make a long story short, the government charged Michael D. Huggins (President of Synthes, NA), Richard Boehnar (Vice President of Operations) and John J. Walsh (Director of Regulatory and Clinical Affairs) with a single misdemeanor count of shipping unadulterated and misbranded Norian XR in interstate commerce. Huggins and Walsh have pled guilty "under the responsible corporate officer doctrine." The other two are expected to plead guilty also.

Precedent has been set, so where is the consistency. Within pharmaceutical organizations, precedent and consistency are what drives ethical behaviors. When that breaks down and the government has to step in, corporate executives need to be held accountable because the "rogue rep," as we are seeing is getting their marching orders from somewhere.

More on Strict Liability here

Abbott Acquires Solvay

Abbott Laboratories' purchase of Solvay SA’s pharmaceutical unit, for about $4.8Beuros or $7.1B, will give it full control of the TriCor cholesterol drug and a bigger presence in emerging markets. This is just another move by a Big Pharma in the ever-evolving chess game to protect the gaps in the pipeline.

Buying Solvay’s drug unit would lower Abbott’s dependence on the arthritis drug Humira, said Larry Biegelsen, a Wells Fargo Securities LLC analyst, in a Sept. 25 note to investors. Humira is the company’s biggest product with $4.5 billion in revenue last year and risks losing sales as consumers and cut spending, as well as CMS reducing reimbursement.

The deal also suggests Abbott is comfortable with the landscape for TriCor and TriLipix, cholesterol drugs it co- promotes with Solvay. Both use the active ingredient fenofibrate, and account for about 20 percent of Solvay’s pharmaceutical sales, Biegelsen wrote.

TriCor faces generic competition by 2011, and Abbott is seeking regulatory approval to market TriLipix in combination with AstraZeneca Plc’s Crestor. TriCor generated $1.34 billion in revenue last year for Abbott, of Abbott Park, Illinois, and 511 million euros for Brussels-based Solvay.


The agreement includes the assumption of certain liabilities valued at about 400 million euros, Brussels-based Solvay said in a statement on its Web site today. Abbott will pay 4.5 billion euros in cash, with as much as 300 million euros in contingent payments between 2011 and 2013. The milestone payments relate to whether products perform well.

Source 

Litmus Test Cited Instead of Asking for Stance on Healthcare Issue

The Senate Finance Committee's health care legislation's discussions came to a head Tuesday night over the deal that the Obama administration cut with the pharmaceutical industry to achieve $80 billion in savings on drug costs over 10 years. Remember, this would be the $80 billion that would help pay for the legislation.


Senator Bill Nelson, (D-FL00) has proposed an amendment that would create a different deal with PhRMA that would keep in place the $80B, while extracting an additional $86B more from the drug industry.

And here's where the time-worn "litmus test" has reared its head.  Senator Charles Schumer (D-NY) is urging the adoption of Senator Nelson's amendment, warning that it would be an "early litmus test" for senators in the health care debate, by posing a clear choice of siding with average citizens or siding with a corporate interest group.


For months now, there have been town hall meetings where there was no doubt how much Billy Tauzin and his band of mauraders were going to contribute to the savings of healthcare reform.  The farce is that now in late September, this is still one more obstacle.

Read more at The New York Times

Senator Grassley has been given $3 million from lobbyists alone.  PhRMA has also added to the treasure chest.  Why now, six weeks before a November election, are we talking about litmus tests between average citizens and corporate interest groups.  It's obvious that the average citizen has not been represented in the discussions.

We have had the elderly, who have Medicare; the Senators and Congressman, who have a pretty good government plan; and we have the occasional underinsured or uninsured who is put on display for the greater good of public relations.

To have all our interests represented, as in "We, the People," it's time to stop using black and white "litmus tests", since the world we live in is actually gray.  More importantly, create legislation that prohibits the vast amount of lobbying dollars that are affecting our governing, but are not really helping our society.