Brass and Ivory: Life with MS and RA

Lisa Emrich

Yesterday was an anniversary of sorts as is tomorrow.

Two years ago on Thursday, December 1, 2005, I took my newly acquired supply of Copaxone to the Neurology Center for injection training. It was both a big deal and not a deal big at the same time. Nurse Carol suggested injecting after a shower when the skin is warm and clean, skipping the alcohol swabs (alchohol on the skin burns on injection!!) It went fairly smoothly but I did develop a largish lump around the injection site.

Nowadays, injections are not a big deal at all. I just do it and go. No ritual. No extra prep. Just do it.

Now more interesting to me is the Saturday after Thanksgiving 2 years ago. I received a phone call from Shared Solutions (Teva's patient front) giving me the good news and congratulations. Below I discuss this particular pivotal point in my personal life, but first...

This year the Saturday after Thanksgiving I received an unexpected call, this time from Dr. Eric Berg, the chiropractor who I discussed previously on this blog. It seems that beyond becoming aware of my blog, he basically had a few things that he wanted me to share with me. One being the concern that an unidentified individual who had communicated to me was in fact under investigation for fraudulent claims. Investigation, that's an interesting word. A scientist may investigate the efficacy of a new drug or I may investigate the cause of my cat's persistent meowing from somewhere near his food bowl. That word alone doesn't indicate much. More information would be needed to supply the context.

Although, congratulations is an odd word to hear after you've recently been diagnosed with multiple sclerosis, your insurance will not pay for the prescribed medication, and you've been left hanging for six weeks after submitting an enormously personal application form to verify your lack of income or resources with which to pay for said medication.

Congratulations!!! You've been approved for 50% by NORD
(National Organization for Rare Disorders).

Yeah!! Wait....50%? What does that mean?

NORD has approved your application and awarded you 50%.

Huh?

You will be receiving six months of medication from NORD and will only need to pay a $100 shipping/handling fee for each 3-month supply.

What happens after six months?

You will need to pay for your medication.

But I don't have that kind of money. I can't afford that.

You can appeal for more assistance, if your financial situation
changes.

So I can appeal in the Spring after I've completed my taxes and have more recent information?

Yes.

(Whew! Okay. I'm alright for now. Now when does that med
arrive?)

Fast forward. Appeal denied!! "You still earned too much at $26K to qualify for additional $10K worth of meds. And you still have some money in the bank. Sorry." I'm paraphrasing, of course. But same result. I ended up spending $16K in medical costs while earning less than $20K.

Okay, finally I'm under that magical 200% Federal Povery Level and I was approved for 100% assistance from NORD this past March.

But the story's not over (is it ever?)

Tomorrow is the last day which I can conduct any banking activity which will not be represented in next spring's application. You see, NORD requires three months of statements from every financial institution which has any of my money. And if it looks like I am able to accumulate any significant amount, I risk forfeiting the opportunity for assistance in the coming year. Yuck!!

That means that I CAN'T take advantage of opportunities to increase investments such as that craziness which is occurring with Questcor's stock. I can't conduct business such as to maximize my own earning power. I basically can't be overtly successful. I just have to ride this out and smile gently each time Nurse Carol asks, "so when is that boyfriend of yours going to propose and ya'll get married? Marriage has benefits you know." Yes, it does, one of which is access to his company-sponsored health insurance which is pretty doggone good.

Health insurance really isn't a good reason to get married in my opinion, but trying to start a family before I turn 40 is. Wait...I think we just passed the point at which it is possible to have a child before I'm 40 next year. Oh well. In the meantime, tomorrow's the last day for any private banking decisions.

Maybe, I'd better investigate the opportunity to maximum the benefits of our relationship.

Rob, sweetie, if you are reading this....I love you and thank you for spending our 30-month + 1 week anniversary on Thanksgiving in Oklahoma with those energetic but adorable nephews of mine!

Lisa Emrich

UPDATE: I have to admit that when I wrote the following, I was rather annoyed by statements I was reading on the Yahoo Financial Message Board discussing Questcor's rising stockprices. My sense of calm logic was spread thin indeed.

[some content deleted]

Well, I'm no expert and I certainly don't get paid for my opinion.

If you are a biotech investor or a pharma industry commentator or even a health policy expert, you are most likely aware that a little company called Questcor has created quite a stir since the summer.

Initially news focused on the non-approval of their sNDA for Acthar Gel's indication for Infantile Spasm, a rare pediatric epilepsy disorder. Then the President and CEO, James Fares, resigns in May.

"Oh...no...we're in trouble!!!," the board seems to say and upgrades one of their own to Interim President to figure out this mess. It's like they are saying, "we're doomed without the FDA on own side."

So what happens? Three board members resign in July, including the Chairman of the Board of Directors, Albert Hansen. Interestingly, the Senior Vice President of Strategic Planning and Communications, Eric Liebler who worked at Questcor for less than one year, resigns three weeks before the Board announces their 'NEW STRATEGY' after which Questcor loses another board member, Gregg Lapointe.

Now, it sure does seem like former CEO James Fares screwed up and jumped ship, but he wasn't the first to resign. [I don't really know the reasons Fares resigned, but I have doubts that strategy suddenly changed after his departure.] In March, Craig Chambliss, Vice President of Sales and Marketing, resigned...the first big player to do so since James Fares 'took the helm' in February 2005.

James Fares, Steven Cartt (Executive Vice President of Commercial Development), Craig Chambliss, and George M. Stuart (Vice President Finance and CFO) have connections to each other from dealings with Elan and Xcel pharmaceutical companies. This is not surprising since new folks in charge will understandably want familiar faces to work with.

Eric Liebler, former Senior Vice President, Strategic Planning and Communications, was hired in October 2006. No doubt in relation to his expertise as Treasurer and Trustee of American Academy of Neurology Foundation. After resigning his position at the end of July, Liebler is staying close by as a consultant.

David Young was appointed to the Board in September 2006. No doubt in relation to his expertise as a PharmD, researcher, and frequent presenter to the FDA. Young became Chairman of the Compensation Committee in July, replacing Virgil Thompson who replaces Albert Hansen as Chairman of the Board.

Just wait.... the shuffle is not done!

Gregg Lapointe was appointed to the Board in July 2005 primarily due to his position as COO for Sigma Tau Pharm (in US-Gaithersburg, MD office) which is a HUGE investor/owner of Questcor. In fact, Paolo Cavazza of Italy owns Sigma Tau and the other affiliated companies which also collectively own no less than 20% of Questcor. Lapointe was also quite useful due to his connections with National Organization for Rare Disorders (NORD), Child Neurology Foundation, and Kidney Cares Partners.

NORD is an organization which administers pharmaceutical assistance programs for many companies who don't want to do it for themselves. They serve as a buffer between the patient and the company. NORD holds the keys but they are not responsible for the contents. [NORD prides itself on being objective, but it has 'run out of funds' a number of times during the past two years...so has said my neurologist. Being denied sufficient assistance, I paid $16,000 for meds last year on an income of $19,500.] Lapointe resigned in August just after the 'new strategy' was announced and the NORD program was beefed-up. You better bet that he made the transition go much more smoothly. Job done...now you can go.

Taking up the position as Rare Disease expert, Robert J. Rubin joined the Board in September just before reports of the successfulness of the 'new strategy.' Rubin is a professor at Georgetown and served as Assistant Surgeon General and Assistant Secretary of HHS in 1981-1984 and in 1987-2001 was president of The Lewin Group, "a premiere national health care and human services consulting firm" in Falls Church, VA (just 3 miles from my home. I wonder if they ever have lunch meetings over at 2941 Restaurant...hmmm.)

Then Questcor appoints Stephen Farrell to the Board as Chairman of the Audit Committee just after releasing the 3rd Quarter results. Followed by upgrading, Don M. Bailey to full-time President and CEO.

Now, I've read some interesting comments that Bailey came in and turned this sinking ship around (hmm..mixed metaphor) 180 degrees. However, it really seems that Fares should be given credit for creating the huge buying opportunity at $0.21 a share this summer to yesterday's closing price of $6.02.

Do the math....that's insane!!

And it's all based on Questcor's dire financial straights as evident from the 2006 annual report where they reported huge, I mean HUGE, losses.
Baloney!! Phaloney!! Rigatoni!!

And today the stock is establishing a new support level at around $5.40.

So what, you say.

Well, just think, one investor Paolo Cavazza purchased 326941 shares between Oct 1-Nov 13 around $1.93-$2.059 a share at a cost of $667,518 which at today's opening was worth $1,961,646. Not bad for a few days of work. Through Sigma Tau and affiliated companies, Paolo Cavazza has owned significant percentages of Questcor since March 2002. Just looking at the shares purchased between March 2002-December 2006, Cavazza could potentially have close to $100,000,000 value of stocks from about $21,000,000 investment, assuming that no profits had been taken during that time.

I also read estimates that former CEO, James Fares, owned around 1,500,000 shares in March 2007 and had over 800,000 vested stock options valued at $0.44 when he resigned in May. I wonder if he exercised those options or did a little purchasing on his own after the stock dropped so low. Nobody could convince me that he didn't exactly know what would occur later this year.

In case any readers think that this is really cool investor stuff, just remember that Questcor has created this dog-and-pony show by exaggerating income losses (IMO) and outrageously increasing the price of their cheaply acquired ($400,000?) Acthar Gel to over $23,000 per vial.

Increase price 15x - Increase revenue 12x = create stock flurry - take profits

That's it folks. Our innovative U.S. healthcare system thriving.

Who cares about the little folks who are being passed the expense?!!

Lisa Emrich

Lisa Emrich

How much influence does the pharmaceutical industry have over your doctor's prescribing habits?

Not only are we (patients) supposed to ask our doctors about such-and-such drug for such-and-such condition, drug reps are attempting to convince your doctor to prescribe such-and-such drug for such-and-such condition because it is supposedly more effective than the other such-and-such drug commonly used.

Today's New York Times Magazine has a wonderful article, "Dr. Drug Rep," written by Dr. Daniel Carlat. During a year of being paid to give talks to doctors about an antidepressant, a psychiatrist comes to terms with the fact that taking pharmaceutical money can cloud your judgment.
(via Over My Med Body!)

On a blustery fall New England day in 2001, a friendly representative from Wyeth Pharmaceuticals came into my office in Newburyport, Mass., and made me an offer I found hard to refuse. He asked me if I’d like to give talks to other doctors about using Effexor XR for treating depression.
[...]
How many doctors speak for drug companies? We don’t know for sure, but one recent study indicates that at least 25 percent of all doctors in the United States receive drug money for lecturing to physicians or for helping to market drugs in other ways. This meant that I was about to join some 200,000 American physicians who are being paid by companies to promote their drugs. I felt quite flattered to have been recruited, and I assumed that the rep had picked me because of some special personal or professional quality.
[...]
Regardless of how I preferred to think of myself (an educator, a psychiatrist, a consultant), I was now classified as one facet of a lunch helping to pitch a drug, a convincing sidekick to help the sales rep.
[...]
One of my most uncomfortable moments came when I gave a presentation to a large group of psychiatrists. I was in the midst of wrapping up my talk with some information about Effexor and blood pressure. Referring to a large study paid for by Wyeth, I reported that patients are liable to develop hypertension only if they are taking Effexor at doses higher than 300 milligrams per day.
“Really?” one psychiatrist in the room said. “I’ve seen hypertension at lower doses in my patients.”
“I suppose it can happen, but it’s rare at doses that are commonly used for depression.”
He looked at me, frowned and shook his head. “That hasn’t been my experience.”

I felt rattled. That psychiatrist’s frown stayed with me — a mixture of skepticism and contempt. I wondered if he saw me for what I feared I had become — a drug rep with an M.D. I began to think that the money was affecting my critical judgement. I was willing to dance around the truth in order to make the drug reps happy. Receiving $750 checks for chatting with some doctors during a lunch break was such easy money that it left me giddy. Like an addiction, it was very hard to give up.
[...]
I still allow drug reps to visit my office and give me their pitches. While these visits are short on useful medical information, they do allow me to keep up with trends in drug marketing.

Lisa Emrich

I started this blog in mid-August, and so far...

42 posts -- not quite as prolific as Kevin, M.D., but certainly not bad for a layperson.

15 blog reactions (Technorati.)

33 visits and 55 page views on average per day (Sitemeter.)

971 visits and 1814 page views since October 9 (Sitemeter.)

129 clicks back to the site on 38 items since August 16 (Feedburner.)

and...

No.544 -- Honorable Mention on the Healthcare Top Blogs List.

Not bad I'd say for a professional musician without a medical, health policy, or journalistic background. Simply an individual patient with a little experience and some thoughtful opinion. For this I am thankful.

I'm visiting my three young nephews and will be silent during the week.

Have a great Thanksgiving!!

Lisa Emrich

Unfortunately, Bush vetoed the FY 2008 Labor-HHS-Education Appropriations bill (H.R. 3043) on Tuesday. The president's action against the health and education funding was not surprising, as he had repeatedly vowed to veto the bill. But the result is still disappointing. This bill would have provided a 3.1% increase for the National Institutes of Health (NIH), including MS research, and a 6% increase for the Centers for Disease Control and Prevention (CDC).

In addition, Congress had incorporated nearly $4 million in funding in the bill for the development of a comprehensive MS center at West Virginia University in Morgantown, W.Va. And it included $2 million for state respite care grants authorized by the Lifespan Respite Care Act (which MS activists helped pass last year).

But here's some good news!

MS Activism Success — New Defense Funding Available for MS Research
(via MSActivist Blog)

For the first time ever, multiple sclerosis research will be eligible for funding under the Department of Defense (DoD). Congress has listed MS as a research area eligible for funding under the DoD's Peer Reviewed Medical Research Programs (PRMRP). PRMRP is a sister program to the Congressionally Directed Medical Research Program (CDMRP) under DoD that we've been working toward all year. This program has a budget of $50 million that can only be spent on research areas that Congress directs. It is a new and untapped funding source for MS research, and will complement the work that NIH is doing to move us closer to a world free of MS. The PRMRP was established in 1999 and continues to fulfill its Congressional intent by funding research of clear scientific merit with relevance to the health of the military and the American public. PRMRP Congressional appropriations have totaled $344.5 million through 2006 and funded 247 projects in more than 60 topic areas. While this program is not the exact line item we asked for, it is a significant gain in our effort to expand research funding for MS in the federal arena. The National MS Society continues to carefully watch emerging evidence from Veterans' Affairs researchers and others that might point to an increased risk of MS among combat veterans. More research must be conducted to better understand a potential environmental trigger. The Defense Appropriations (H.R. 3222) funding bill was signed by the President on November 13, 2007. As the program is implemented, we will let you know how researchers and others can apply for this funding. Thank you again for all your hard work and MS activism on this issue. We will need your voice again next year.

U.S. Representatives Leading the Congressional MS Caucus

Co-Chairs
Russ Carnahan (D-MO)
Michael Burgess (R-TX)

Members (as of 11/13/07)
Neil Abercrombie (D-HI)
Tom Allen (D-ME)
Tammy Baldwin (D-WI)
Marion Berry (D- AR)
Brian Bilbray (R-CA)
Leonard Boswell (D-IA)
Lois Capps (D-CA)
Mike Castle (R-DE)
Wm. Lacy Clay (D-MO)
Tom Cole (R-OK)
Barbara Cubin (R-WY)
Susan Davis (D-CA)
Diana DeGette (D-CO)
Lloyd Doggett (D-TX)
Keith Ellison (D-MN)
Bob Filner (D-CA)
Randy Forbes (R-VA)
Virgil Goode (R-VA)
Bart Gordon (D-TN)
Gene Green (D-TX)
Tim Holden (D-PA)
Darrell Issa (R-CA)
Marcy Kaptur (D-OH)
Patrick Kennedy (D-RI)
Peter King (R-NY)
Barbara Lee (D-CA)
Frank Lobiondo (R-NJ)
Zoe Lofgren (D-CA)
Edward Markey (D-MA)
Jim Marshall (D-GA)
Thaddeus McCotter (R-MI)
Jim McDermott (D-WA)
Jim McGovern (D-MA)
Cathy McMorris Rodgers (R-WA)
Michael Michaud (D-ME)
Dennis Moore (D-KS)
Tim Murphy (R-PA)
Grace Napolitano (D-CA)
James Oberstar (D-MN)
Donald Payne (D-NJ)
Collin Peterson (D-MN)
Chip Pickering (R-MS)
Todd Platts (R-PA)
David Price (D-NC)
Deborah Pryce (R-OH)
Adam Putnam (R-FL)
Dave Reichert (R-WA)
Rick Renzi (R-AZ)
Tom Reynolds (R-NY)
Steve Rothman (D-NJ)
Pete Sessions (R-TX)
John Shadegg (R-AZ)
Christopher Shays (R-CT)
Adam Smith (D-WA)
Vic Snyder (D-AR)
Patrick Tiberi (R-OH)
Fred Upton (R-MI)
Henry Waxman (D-CA)
Peter Welch (D-VT)

(hattip and thanks to MSActivist Blog)

Lisa Emrich

Maggie Mahar at the Health Beat Blog hosts this week's Health Wonk Review. A vast array of articles are featured. Go check it out!!

Lisa Emrich

An excellent article appears at The New Republic. Jonathan Cohn discusses 'The best case against Universal Health Care' in his article "Creative Destruction."

This is an absolute must read...

Besides, true innovation ultimately benefits everybody by pushing the boundaries of the medically possible. Can we really count on a universal coverage system to weigh all of that? In other words, can we really be sure that universal health care won't come at the expense of innovative medicine?

This [scrutinizing treatments for cost-effectiveness] , in turn, would lead to both less innovation and less access to the innovation that already exists. And the public would end up losing out, because, as Tyler Cowen wrote last year in The New York Times, "the American health care system, high expenditures and all, is driving innovation for the entire world."

Consider this innovative treatment for Parkinsen's disease --

The story of Deep Brain Stimulation actually holds some important lessons about how innovation frequently takes place--and why it's not all that dependent on a non-universal, private health care system like the one we have in the United States. For one thing, it turns out that DBS isn't exactly an American innovation. If anybody deserves credit for developing it, it's the French--and one French doctor in particular.

That doctor's name is Alim-Louis Benabid...A recently retired neurosurgeon who did his work at the University of Grenoble, near the French Alps...

Did the for-profit system drive this innovation? --

In this sense, DBS offers an important window into the way medical innovation actually happens. The great breakthroughs in the history of medicine, from the development of the polio vaccine to the identification of cancer-killing agents, did not take place because a for-profit company saw an opportunity and invested heavily in research. They happened because of scientists toiling in academic settings.

According to Robert Gross, an Emory University neurosurgeon and expert in the field, Benabid had actually approached the companies that already made electrodes for use in treating chronic pain, suggesting they develop a device specifically for Parkinson's. But they declined initially, so Benabid had to use the existing devices and adapt them on his own. "The companies did not lead those advances," Gross says. "They followed them."

So who does lead medical innovation? --

"The nice thing about people like me in universities is that the great majority are not motivated by profit," says Cynthia Kenyon, a renowned cancer researcher at the University of California at San Francisco. "If we were, we wouldn't be here." And, while the United States may be the world leader in this sort of research, that's probably not--as critics of universal coverage frequently claim--because of our private insurance system. If anything, it's because of the federal government.

The single biggest source of medical research funding, not just in the United States but in the entire world, is the National Institutes of Health (NIH): Last year, it spent more than $28 billion on research, accounting for about one-third of the total dollars spent on medical research and development in this country (and half the money spent at universities). The majority of that money pays for the kind of basic research that might someday unlock cures for killer diseases like Alzheimer's, aids, and cancer. No other country has an institution that matches the NIH in scale. And that is probably the primary explanation for why so many of the intellectual breakthroughs in medical science happen here.

But what has happened to NIH funding in recent years? --

It so happens that, starting in 2003, President Bush and his congressional allies let NIH funding stagnate, even though the cost of medical research (like the cost of medicine overall) was increasing faster than inflation. The reason? They needed room in the budget for other priorities, like tax cuts for the wealthy. In this sense, the greatest threat to future medical breakthroughs may not be universal health care but the people who are trying so hard to fight it.

And once again, President Bush is threatening the veto the Labor-HHS-Education bill (H.R.3043) which would provide much needed funding for medical research.

Congress has incorporated nearly $4 million in funding in the bill for the development of a multiple sclerosis and neurodegenerative disease research center at West Virginia University in Morgantown, W.Va. This first comprehensive center for MS research and care in West Virginia holds great promise for people living with MS not only in the state but nationwide.

In addition to this specific funding for MS, the Labor-HHS bill includes a 3.1% increase for the NIH, a 6% increase for the Centers for Disease Control and Prevention (CDC), and $2 million for state respite care grants authorized by the Lifespan Respite Care Act (which MS activists helped pass last year).

Lisa Emrich

So Questcor finally releases their 3rd quarter earnings report which includes 1 month of sales of H.P.Acthar Gel after raising the price 15 fold at the end of August.

News from the Yahoo message board - Very telling

mastered: "QSC now a CASH COW with blockbuster drug in captive market."

Read my previous posts for more information regarding Questcor's use of Orphan Drug Status and claims of Income Losses to justify the price increase from ~$1600 per vial to $23,265 per vial.

From the 3rd quarter earnings report:

Demand by patients utilizing Acthar for infantile spasms (IS) and opsoclonus myoclonus syndrome (OMS) has remained at approximately the same levels experienced prior to the implementation of the new strategy.

Notice the lack of reference to MS patients. I can't speak for other MS doctors, but Acthar is off-the-table now for use in exacerbations in my neurologist's office directly due to the price increase. Solumedrol IV is the preferred drug anyway. But I'm sure that Questcor knows this already.

Questcor has also seen a positive pattern of insurance coverage and expanded use of the safety net programs [ie. NORD] for Acthar patients.

So...insurance companies are paying the 1500% increased price? Where's the cost control? Negotiated rates anybody? Out-of-pocket maximums or benefit limits? And if Questcor is not directly funding the safety-net programs 100% at NORD, then they are sucking resources away from other programs, or are draining the financial reserves of the patients.

As a result, Questcor is not aware of a single IS or OMS patient requiring Acthar that has been denied treatment.

Ahh...now doesn't that make you feel good? Not!

Being denied treatment is not the same as being denied coverage, being denied assistance, being denied reimbursement, or simply being denied the prescription in the first place. Perhaps doctors are choosing alternatives even if they have to be purchased from Canada.
BTW: Questcor moved the manufacturing of Acthar to Canada.

While the trend in ordering and insurance reimbursement has resulted in higher net sales, as Questcor expected, since the implementation of its new business model, overall unit demand for Acthar has decreased significantly.

Net sales of Acthar were $14.6 million and $21.8 million, respectively, for the three and nine month periods ended September 30, 2007 as compared to $3.8 million and $9.0 million for the same periods in 2006.

In June 2006 Questcor submitted a Supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) and is currently pursuing formal agency approval for Acthar in the treatment of IS. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS. As a result of this Orphan Designation, if Questcor is successful in obtaining FDA approval for the IS indication, Questcor will also qualify for a seven year exclusivity period during which the FDA is prohibited from approving any other ACTH formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.

Ahh...the power of evidence-based medicine to provide market exclusivity and tie the government's regulatory hands.

On November 9, 2007, Questcor met with the FDA to further discuss its sNDA seeking approval of Acthar for the treatment of IS. At the meeting, the FDA concurred with Questcor’s suggested pathway to preparing a complete application for FDA review.

Shouldn't the original application have been complete? Come on.

Since the implementation of the new Acthar strategy, Questcor estimates that end user demand for Acthar has been 425 to 475 vials per month. Of this demand, Questcor estimates that approximately 30 percent of vials are used by patients covered by Medicaid and other government related programs.

Ok. Let's make some assumptions here and use 450 vials for demonstration purposes only.

$23,265 price per vial x 450 vials = $11.05 million

Plus 4 extra days at new price in August...maybe 65 vials = $1.51 million

Total net sales for Acthar in Q3 = $14.6 million

Net sales for Acthar in 8 weeks July/August = $2.0 million?

$2.0 million / $1600 price per vial = 1250 vials

So from ~625 per month demand down to ~450 per month, significant decrease AND Questcor was able to match 2006 total sales of $12.1 million in only one month.

Shouldn't the payors be concerned? I know the investors are happy.

For periods after September 30, 2007, the amount of Medicaid rebates and government chargebacks that reduce Questcor’s net sales may result in minimal, if any, net sales revenue to Questcor from products used by Medicaid patients and certain government entities. As discussed above, Questcor has experienced a consistent level of ordering and insurance reimbursement for Acthar since the inception of the new strategy.

Good...Questcor will not be allowed to drain government funds in a greedy manner. But I'm still curious to know how the level of ordering and insurance reimbursement compares before and after the new strategy.

~~~
More interesting discussion from the Yahoo message board last night:

cjc11730: The earnings may be hard to decipher. The price increase went into effect on Aug 27th. There was only one month left in the quarter (Sept); and insurers normally run at least a 2 week lag time. It would be nice to know how many orders were placed in Sept and approved overall. Another key is will they give guidance as to what is the total number of orders placed and approved in October and early November. Good deal of variables here.

chopper: Keep in mind they STILL have not told the public why the FDA rejected their proposal last March, and what/if any outcome from the conversations they said the FDA requested. This company is not big on making information public.

bernie: I'm curious as to if these orders were mostly in "Mid-Stream" when the price change was made. Futhermore, most of the patients would have stayed with the treatment.... What makes me "nervous" is this... "Is Acthar going out with a bang". (Management: Make as much out of the drug before running it into the ground?)
jillp: Does it really matter today. It is about making money. It is time to get an advantage from positive news. the last year has been painful.

chopper: >>Futhermore, most of the patients would have stayed with the treatment....<<> In fact, it is very dangerous to suddenly withdraw a steroid treatment, so there was little choice in the recent decisions. There will be more choice for those considering treatment for the first time, and I think they "eluded" (LOL) to this in the PR.

medexpert2: At the end of the release, it was noted that as of November 9, there was 15 million in cash and 22 million in accounts receivable. At September 30, just 40 days earlier, there was 10 million in cash and 14 million in accounts receivable! Hold on for the ride of your life, boys and girls!

bernie: Does anyone besides myself see it as strange, that QSC isn't having a CC to accompany the earnings release? Could be too many tough questions....

dochollywood: Yes very strange. Great news, future, and FDA interactions. The volume and price suggest good times ahead of the company. The value is still $300mm based on the numbers even if the medicaid 1/3 is discounted. There was only 1 month of increased profits in these number. 3 times revenue for valuation is not unreasonable. So it seems as though the price should increase over $3.00 accordingly.

coyote: You made a good point, Bernie. However, the reason could well be, because the PR and financial results told us a very compelling story in itself, ......that they felt was adequate and sufficient at this time. I thought the various data submitted for public review, revealed many good things to us.

bernie: Personally, if I were management and produced such extreme results I would be screaming it from the "roof tops", and on "every forum".... The 3rd Quarter Sales were comparable to the entire year of 2006? Maybe, they didn't want any supposed "renagade shareholders", to express their concern in regards to "children dying" due to price gouging, etc.?... Who knows, but strange in my book.

coyote: Adverse market conditions we have been seeing on and off, appear to be helping dictate the course of our share price, at least to some extent, for some of our trading today. I am pleased with the overall progress we have made recently, and the very strong showing for today! May the Gods continue to shine down upon us, and give us guidance with our endeavors.

chopper: Bernie, first of all, congratz on persisting with this. Of course this windfall is based on two things (and hindsight is always 20/20) - the decay that occurred under Fares which created a buying opp, and then the stroke of a pen which changed the price of their (mainly) single product by a factor of 15. For those who guessed correctly that this would happen (I can't envision any other scenario that would have created this runup, since there was no way the MS community, or any of the "54 indications" was going to latch on to Acthar in any meaningful way), congratz to you too. I had no idea they would do this, and still wonder why they didn't do it sooner, but maybe they wanted the buying opp too. In the end, jacking the price up when you have an effective monopoly can make you a lot of money, but even more when you've allowed your share price to sink like a rock. I laugh at all the comments about "we did this to keep Acthar available" because we all know they did this to keep QSC viable. If QSC went under, there is no way Acthar would disappear. Companies are in business to make money, period. I think this is the first quarter in a long time that they've not had a cc, but I suspect they may feel like they are tip toeing across a high wire, and didn't want any wind blowing. In other words, your "too many tough questions" is right on. It will be interesting to see how they spend all this windfall - research and clinical trials aren't cheap, and could well move them back to a non-profitable situation. But this is all well down the road - after all, it took them 6 months to meet with the FDA (which they misleadingly claimed they were required to do before explaining the reasons for the NDA rejection). Good luck to all.

elmccann: >>In the end, jacking the price up when you have an effective monopoly can make you a lot of money<<>>I laugh at all the comments about "we did this to keep Acthar available"<<>who do they think they are kidding? They are also trying to convince the IS community that they will invest in research. Any decent research will help determine which patients do not benefit from ACTH - clearly not something they are going to pursue. If I was trying to hide the truth, I would not have a cc either.

~~~

cjc11730: Does anyone want to venture an intelligent guess on the price per share if they can sustain the 11-12 million dollar per quarter (or 45 million per year) allowing for the medicaid give backs?

jillp: Well the revenues are from 1 month of higher profits and charges. So $45 is low. It is more like $12mm-2mm(regular revenues)=$10mm. So say it is low like $8mm(per month) x 12 months=$96mm x.67 Medicaid discount)=$64mm. If you do 3-5 times revenues as a reasonable valuation then value is $180mm to $300mm. Not counting the cash they have now and the other program QSC100.

medexpert2: I would say $9.60 per share. .12 x 4 quarters = .48, multiplied 20x earnings = $9.60. This is a no-brainer boys.

bernie: My main question is... How quickly do they lose market share in regards to competing medications?

jillp: Orphan drug-----standard of care would you take the risk as a treating md?

coyote: Over 7.5M shares traded today, and changed hands. My intuition tells me we should have another big day tomorrow, because the financial world has taken notice of our little company, by virtue of what took place today. A good word travels fast.

~~~

Interesting isn't it? Money doesn't magically grow on trees -- it has to come from somewhere. Where do you think the insurance companies will find the $12 million each month to pay Questcor a obscenely bloated price for a 50+ year old drug for which they do not even own a patent?

It's enough to make my stomach churn!!

Lisa Emrich

According to reporter Zoo Knudsen and the CDC, "Tests Reveal Higher Cootie Levels Than Expected in Children..."

The lead investigator explains, "So we can't blame this on, say, the recently discovered increases in the number of nerds, geeks, dweebs, goobs and hyperdweebs in most regions. Some of these kids were pretty cool. Jocks, cheerleaders, homecoming queens, girls who put out on the first date, mysterious new kids with dreamy eyes and a troubled past. Nobody was spared."

Zoo reports that young celebrities are calling for more Cootie research.

I was thinking of a simple solution. Perhaps mothers of young children should organize 'Cootie Parties' much similar to modern 'Chicken Pox Parties' at the first sign of outbreak within their Playdate Group. Children exposed to the virus early on could develop sufficient immunity to prevent more significant complications down the road.

For complete coverage of the story, read here...

Lisa Emrich

update (11/24): Dr. Haig's article, discussed below, has received a backlash of attention including this piece in the New York Times and this post by Dr. Val. Apparently, Dr. Haig touched many readers and bloggers, including Trisha Torry at Every Patient's Advocate and Matthew Holt at The Health Care Blog.

Dr. Scott Haig wrote an interesting article regarding patients who seem to have a little too much information at hand, "When the Patient is a Googler."

Every doctor knows patients like this. They're called "brainsuckers." By the time they come in, they've visited many other docs already — somehow unable to stick with any of them. They have many complaints, which rarely translate to hard findings on any objective tests.

So some patients can be rather difficult to deal with. However that is a truism for many human encounters. Some people are simply difficult and a series of unproductive experiences seem to further feed the source of that particular personality trait.

So Dr. Haig's experience with patient Susan got him "thinking about patients." He likes nurses who know the medical language and typically trust doctors. He likes engineers because "they're logical and they're accustomed to the concept of consultation — they're interested in how the doctor thinks about their problem."

If your orthopedist thinks about arthritis, for instance, in terms of friction between roughened joint surfaces, you should try to think about it, generally, in the same way. There is little use coming to him or her for help if you insist your arthritis is due to an imbalance between yin and yang, an interruption of some imaginary force field or a dietary deficiency of molybdenum. There's so much information (as well as misinformation) in medicine — and, yes, a lot of it can be Googled — that one major responsibility of an expert is to know what to ignore.

"That one major responsibility of an expert is to know what to ignore."

I agree wholeheartedly!

"A seasoned doc gets good at sizing up what kind of patient he's got and how to adjust his communicative style accordingly."

I understand this concept well as it is something I do on an hourly basis with my students. One approach which works with 2nd-grader Susie may not be successful with 8th-grader Johnnie. Each student needs a personalized approach which still leads to the ultimate goal of developing a treasure chest of knowledge, experience, physical awareness, expressive control, and the problem-solving skills to enable the musician to become a self-sufficient interpreter of musical text and a creator of musical experience.

However, sometimes grand generalizations and assumptions can be misleading. Take for instance, the story Dr. Val relayed yesterday regarding a friend's painful experience in the ER, "The Benefit of the Doubt: Have Healthcare Professionals Lost It?" Sizing people up is a good skill to have, but not when the concerns of the patient are dismissed or neglected.

Doctors, please, trust your patient otherwise you feed their suspicions and distrust of doctors in general.

At the other end of our spectrum are patients like Susan: They're often suspicious and distrustful, their pressured sentences burst with misused, mispronounced words and half-baked ideas.

Today Dr. Val responds to Dr. Haig and tells us "Why Doctors Are Better."

Health information is more plentiful and accessible to patients than ever before. As a physician I am thrilled that people are empowered with knowledge to take control of their health, but I am also sincerely worried about the "misses:" misinformation, misconceptions, misdiagnoses and mistakes.

Information and knowledge alone are insufficient in deciphering the complexities of the human body and its reactions to internal and external stimuli. And with the growth of 'evidence-based medicine,' doctors are provided with, and hopefully contributing to, the collective science and knowledge regarding these complex physiological, chemical, emotional, cellular, and cultural interactions.

Google cannot remove the irrelevant, because it can't evaluate the science behind various claims, appreciate the nuances of an individual's life circumstances, or confirm a diagnosis.

The master sculptors in health information are physicians - trained for at least a decade in the art of analyzing data, appreciating the connectedness of various symptoms and body systems, and focused on chipping away at the irrelevant to uncover personalized solutions and cures - they are the artists whose experience and insight can make the difference between life or death.
... Information in the hands of a person who can apply it in an intelligent, personalized, and relevant way is our best shot at good, quality healthcare. There is an art to medicine, and the trick is to know what to ignore.

Once again I agree.

But, please!!

Do not ignore the patient.

Lisa Emrich

This week's Cavalcade of Risk is hosted by finance-blogger Super Saver at My Wealth Builder. Under the category personal risk, you'll find my recent post regarding Medicaid, Disabled Persons, and Affordable Housing. Be sure to go check out the collection of posts.

Lisa Emrich

As I continue to learn about the economics of health policy and the politics of entitlement programs, I contemplate the intersection and disconnect of various safety-net and hand-up programs.

On February 1, 2001, President Bush announced the New Freedom Initiative - a comprehensive program to promote the full participation of people with disabilities in all areas of society... On July 27, 2007, the White House released the 2007 Progress Report on the New Freedom Initiative which is President George W. Bush's plan to tear down barriers to full integration into American life that remain for many of the 54 million Americans with disabilities.

As part of the New Freedom Initiative, DisabilityInfo.gov, a federal one-stop online resource and collaborative effort among twenty-two federal agencies, connects people with disabilities to the information and resources they need to actively participate in the workforce and in their communities. While perusing the website, I found the legislative foundation of Virginia's Medicaid Works program I discussed previously.

Enacted on December 17, 1999, the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA) includes several incentives and opportunities for successful work experiences for people who receive Social Security disability benefits who want to go to work. This landmark legislation modernizes the employment services system for people with disabilities and makes it possible for millions of Americans with disabilities to no longer have to choose between taking a job and having health care.

The Virginia Work Incentive (WIN) program, Medicaid Works, is a Medicaid Buy-In program available to disabled enrollees, under 65, who are employed or wish to be employed. To qualify for Medicaid Coverage, an individual's income must be below 80% Federal Poverty Level (FPL) which equates to $8168 for an individual in 2007 and $10,952 for a couple. Initial eligibility also requires the applicant to have resources limited to $2000 for individual or $3000 for couple.

Continued participation in Medicaid Works requires that all earned income be deposited into a WIN account, maintaining $2000 minimum balance. Any amounts deposited into IRS-approved accounts do not count against resource limits and will not affect continued eligibility. Examples of IRS-approved accounts include IRA, MSA, MRA, education accounts or independence accounts.

According to the Medicaid Works Handbook, the Virginia program allows the disabled Medicaid recipient to earn income up to $40,905 and to accumulate resources up to $27,577 which far exceed general Medicaid limits. Following are the Principles for Development of the Medicaid Buy-In Program in Virginia. Consider carefully the bold statements [my emphasis].

1. To remove barriers to employment in order to allow Virginians with disabilities to maximize their potential for personal growth and independence.

Persons with disabilities should have the option and opportunity to work and boost their self-sufficiency. Fear of losing health insurance coverage has been identified as a barrier to employment for individuals with disabilities. No one should have to choose between going to work and having health insurance coverage, nor should taking a job put you at greater financial risk than remaining unemployed.

2. To provide opportunities for persons with disabilities to increase their financial security and independence by accumulating assets.

Enable individuals with disabilities to increase their financial independence through accumulated assets that make it possible for them to respond to short term emergencies, to save for retirement or for their families’ needs. It is important for all Virginians to have the opportunity to participate in the American dream. People with disabilities who go to work should have the opportunity to save and plan for the future just like everyone else.

3. To promote a coordinated and integrated program/process that positively impacts the workforce and the community, and assures the consumer that no harm will result from participation in the program.

Keep the program simple and easy to understand. Enable a smooth transition both to and from the program, including safeguards to ensure participants who acquire resources/savings (e.g., increased resource limits) will not adversely impact their eligibility for Medicaid in the event their employment ends. The Buy-In will encourage people with disabilities to enter the competitive workforce, thus, expanding the labor pool for employers with willing, capable individuals who will work hard, pay taxes, and be further engaged in community life.

4. To encourage and support Virginians with disabilities who engage in gainful employment in a competitive environment.

Provide individuals with the opportunity to retain vitally important health care coverage so that they may confidently participate in the workforce without fear of financial instability due to personal health care needs. However, the purpose of this program must include the expectation that buy-in participants are engaging in meaningful work with earnings that will help in meeting their financial needs as well. Virginia's Medicaid Buy-in should promote the idea that individuals with disabilities can compete in the workplace and earn sufficiently to gain a measure of true independence.

5. To create a fiscally responsible system that benefits Virginians with disabilities.

It is important to ensure that Virginia’s MBI program is economically feasible. The Advisory Committee, and all partners in the development of our State’s program, should be thorough and examine all program options carefully, to ensure that Virginia does not experience unintended consequence (i.e., enrollment/costs that far exceed projections, or a program so restrictive that few people take advantage of it). Assist in developing a system that supports people in going to work, rather than one that merely expands Medicaid. The MBI Program should be a true “buy-in” for participants, wherein individuals will share in the cost of health care coverage, at a reasonable level that still makes it possible for them to provide for other needs.

I especially enjoy the ideology behind these statements although I do not fit the criteria to participate in Medicaid Works:

It is important for all Virginians to have the opportunity to participate in the American dream.
No one should have to choose between going to work and having health insurance coverage, nor should taking a job put you at greater financial risk than remaining unemployed.
The MBI Program should be a true “buy-in” for participants, wherein individuals will share in the cost of health care coverage, at a reasonable level that still makes it possible for them to provide for other needs.

Although it is not the same thing, Bob Laszewski discusses a Medicare Buy-In program over at Health Care Policy and Marketplace Review.

For individuals and families with low- to moderate-income, home ownership is often the part of the American dream which remains a dream. After being denied the additional assistance I needed in 2006 for prescription medication, I looked into local programs designed to assist low- to moderate-income individuals in achieving home ownership. What I discovered was that I didn't earn enough income to qualify.

The City of Falls Church Housing and Human Services (HHS) Division establishes income limits for the Affordable Dwelling Unit (ADU) Program based on the U.S. Department of Housing and Urban Development (HUD) Area Median Income for the Northern Virginia/DC Metro Area. In 2007, the Median Family Income (MFI) in the Northern Virginia MSA is $94,500 for family of 4. $60,000 qualifies as low-income for a family of 4 and $42,000 for an individual according. HUD defines very low-income as 50% Median Income which becomes $33,100 for an individual and $47,250 for family of 4. The lowest range for HUD is 30% Median Income which is $19,850 for an individual and $28,350 for family of 4.

As of April 23, 2007, the City of Falls Church Affordable Housing Income Limits are $33,075 - $52,920 for an individual, $37,800 - $60,480 for family of 2, and $47,250 - $75,600 for family of 4. These numbers correlate to minimum income at 50% Median Income and maximum income at 80% Median Income. Current available Affordable Dwelling Units in Falls Church include seven 1-bedroom units at $98,229 each and eight 2-bedroom units at $136,168 each in the Pearson Square complex located less than 1/2 mile from where I live. Also available are three 1-bedroom units at $113,876 each and five 2-bedroom units at $146,412 each in the Spectrum at Falls Church complex only 1 mile away.

Now here's the irony. If I were declared disabled by Social Security Administration, I could take the risk of allowing my income to fall to $8168 while depleting personal savings to $2000 to qualify for participation in the Medicaid Works program. Then I could earn up to $40,905 (400% FPL or 61.7% MI), have Medicaid coverage, save for retirement and maintain personal savings of $27,577, and qualify to purchase an affordable housing unit within the community I live and work.

However, that is a risk I am not brave enough to take.

Lisa Emrich

Hank Stern, known as The_Prof at InsureBlog, hosts a 'historical' Health Wonk Review.

You may have thought that today was simply known as All Saints Day. Au Contraire--prepare to get educated while being entertained as he features all that is tragic, deceptive, and potentially effective in Health Care Policy today.

And in a charitable act, The_Prof includes my post discussing the need for improved Integrative Medicine.

In the Pursuit of Health & Wellness -- Is Alternative Medicine Complementary?

(Thank you for including a post-deadline post.)

Brass and Ivory: Life with MS and RA

Friday, November 30, 2007

Odd Anniversaries - Health/Wellness, Rare Disorders, Insurance, Money and MS

Questcor's 'REAL' Strategy creates Huge Opportunities for PROFIT!!

Wednesday, November 28, 2007

Multiple Sclerosis Community and Resources

Sunday, November 25, 2007

Doctors are Human Too

Sunday, November 18, 2007

Measuring Big Milestones and Giving Thanks

Thursday, November 15, 2007

New Funding Source for MS Research

Wednesday, November 14, 2007

Health Wonk Review is Up at Health Beat!

Tuesday, November 13, 2007

Would Universal Health Care Stifle Medical Innovation?

Questcor (QSC) Announces Q3 Earnings -- Please read the report, then explain to me how market forces can curb rising healthcare costs in America

Saturday, November 10, 2007

Cootie Rise Concerns Zoo Reporter

Friday, November 9, 2007

Google--Patient Empowerment or Patient Annoyance?

Wednesday, November 7, 2007

Cavalcade of Risk #38 Is Up!

Monday, November 5, 2007

New Freedom Initiative -- Medicaid, Employment, and Affordable Housing for Disabled Persons

Thursday, November 1, 2007

Today in History -- Health Wonk Review is Up!

Thank you, Judy

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