Biosimilar Drugs and NOT the same as Biogeneric Drugs

For a little history on the topic of biogeneric drugs, read the following Brass and Ivory articles:

When Will We Have the Option of Generic MS Self-Injectable Drugs? (March 25, 2008)

Generic Biotech Drugs -- The House Energy and Commerce Committee meeting to consider establishing a Regulatory Pathway for Follow-On Biologic Drugs (October 24, 2007)

Today, Gooz News published the following article which addresses a significant difference which proposed legislation will have on patients using expensive biological drugs, such as the MS disease-modifying drugs.

Biogenerics, Not Just Biosimilars

The debate over a regulatory pathway for biotechnology generic drugs is shaping up and it doesn’t look good for cost-conscious patients or anyone pulling their hair out over rising health care costs.

Last week, both Merck and Eli Lilly announced plans to expand their biotechnology divisions. While they are taking aim at proteins already on the market, both companies told the press that their new biotech drugs would not be generics in the traditional sense. They will be slightly modified versions of existing drugs that will be run through the full panoply of clinical effectiveness testing and sold at prices much closer to the original drug.

In essence, both companies are banking that the “biosimilar” legislation that now seems destined to pass Congress next year will bring into existence a biotechnology me-too industry. That’s very different than a true generic industry, which was created by the Hatch-Waxman Act of 1984 for traditional drugs.

Unlike true generics, which are exactly like the original drug, me-too drugs contain slight modifications that qualify for their own patent protection. Their clinical usefulness may be no different or only slightly improved from the original. But, because they have been put through their own clinical trials and have patent protection, they can be marketed to physicians as unique products and priced accordingly.

The results are often of marginal benefit to patients, consumers and health care plans. Me-toos are usually priced within 10 to 20 percent of the original drug’s price, and sometimes cost more if they have marketable benefits like less frequent dosing. True generics, on the other hand, usually cost less than half of the original molecule because multiple firms jump into the fray and there is no direct-to-consumer or direct-to-physician marketing to inflate costs.

Read the remainder of the article at Gooz News which ends with this:

Clearly, it’s going to take a lot of consumer and payer pressure to get legislation that offers fast and meaningful economic relief from the high cost of biotech drugs when their patents expire. Changes in patent law to enable a me-too biosimilar industry isn't even half a loaf. What the public needs is a pathway to biogenerics that doesn't require costly, duplicative clinical trials.

I've not been keeping up with recent developments, but it's time to get back into following pharma and congress.

Provigil - 28% Price Hike since March 2008

Dear Brass and Ivory readers,

I thought that you would enjoy (or cringe) reading the following by Ed Silverman of The Star-Ledger of New Jersey. To put things more into perspective - the current per pill rate allowed by my insurance company is about $11 whereas two years ago it was $9.

In 2006, I was taking 2 pills per day. Now I only use Provigil as needed and then only half a tablet. Since I have insurance with prescription coverage, Cephalon considers me ineligible for their assistance program. Arrgh.

Fighting Generics, One Price Hike At A Time
from Pharmalot by Ed Silverman

Twice this year, Cephalon has sharply raised the price of its Provigil narcolepsy drug, which is now 28 percent more expensive than in March and 74 percent more expensive than four years ago, and the drugmaker said recently it plans to continue raising the price, The Wall Street Journal writes.

The Provigil price increases - the average wholesale price is now $8.71 a tablet - are an extreme example of a common tactic drugmakers employ in the US to boost profits and steer patients away from cheaper generics, the paper continues.

Here’s how it works: Knowing that Provigil will face generic competition in 2012 as its patent nears expiration, Cephalon is planning to launch a longer-acting version of the drug called Nuvigil next year. To convert patients from Provigil to Nuvigil, Cephalon has suggested in investor presentations it will price Nuvigil lower than the sharply increased price of Provigil, the Journal writes.

By the time generic versions of Provigil arrive, Cephalon hopes that most Provigil users will have switched to the less-expensive Nuvigil, which has patent protection until 2023. Meanwhile, Cephalon will have maximized its Provigil revenue with the repeated price hikes, the paper explains.

“You should expect that we will likely raise Provigil prices to try to create an incentive for the reimbursers to preferentially move to Nuvigil,” Chip Merritt, Cephalon’s vp of investor relations, told a recent health care conference, according to a transcript. Cephalon acknowledges regularly increasing prices, although until this year, the drugmaker says Provigil prices were rarely raised and offers a patient assistance program, but that couldn’t accommodate everyone who sought help.

Interestingly, just last week, Cephalon ceo Frank Baldino told a biotech conference that drugmakers should lower prices to avoid being in the crosshairs of the federal government. “It’s time to reconsider the pricing model,” he said, according to Dow Jones. “Perhaps it’s time to move toward a volume model” in which higher sales volumes make up for lower prices.

Provigil’s price increase over the past four years has been almost four times steeper than the 4 percent compound annual growth rate of the average drug price during that period, according to a DestinationRx, the Journal writes. The paper adds some insurers say may find it too costly to keep patients on Provigil once Nuvigil is introduced because generic Provigil will still be two years off.

“It’s really hard to take a higher price now for a lower price in the future when the future is very far away,” Edmund Pezalla, national medical director for Aetna Pharmacy Management, tells the Journal.

Since some patients take Provigil to help stay awake for various reasons, such as work, a portion of sale are off-label In September, Cephalon agreed to plead guilty to one misdemeanor count of violating the US. Food, Drug and Cosmetic Act and to pay $444 million to settle federal and state allegations that Provigil and two other drugs were promoted for off-label usage (back story).

Montel Williams will be Lobbying against Price-Negotiation for Medicare Drugs

The pharmaceutical industry is not so keen in government having the power to negotiate drug prices for Medicare users. This on top of the fact that Medicare Part D has been a windfall for Big Pharma and they don't want anything to interfere with that.

Read below how PhRMA plans a media blitz to work against Obama's health policy agenda. I'm sad to see that Montel l has devoted his face and voice for the effort.

Hat Tip: David Williams at Health Business Blog - "Is Big Pharma Preparing to Shoot itself in the Foot?"

Drugmaker ads to target Obama idea
Lobbyist readies for prescription price fight
Sean Lengell, The Washington Times
Friday, November 14, 2008

The nation's largest pharmaceutical lobbying group is preparing a multimillion-dollar public relations campaign to tout the importance of free-market health care and undercut an expected push by the Obama administration for price controls of prescription drugs.

The effort, which will include a national television commercial scheduled to begin airing next week, is the first salvo in what likely will be a huge battle over health care reform during the Obama presidency.

Other major industries are also gearing up for the fight, including big businesses and insurance companies. But the stakes are especially high for drugmakers, which stand to lose as much as $30 billion in revenue if President-elect Barack Obama's plan to let the federal government negotiate Medicare drug prices is implemented, according to one independent report.

"There's no question that next year will be a challenging year," said Ken Johnson, senior vice president with the Pharmaceutical Research and Manufacturers of America, or PhRMA, which is organizing the campaign.

Mr. Obama attacked drug companies repeatedly during his election campaign.

PhRMA says its upcoming advertisement, which will feature TV talk show host and PhRMA spokesman Montel Williams, doesn't criticize the pending Obama administration or any of its health care proposals.

"We're going to do an ad campaign that is designed to make people aware of the importance of preserving your free-market health care system," Mr. Johnson said.

He added that PhRMA recognizes that "some reforms are needed in order to keep that system vibrant."

Mr. Johnson said PhRMA would've embarked on exactly the same ad campaign if Mr. Obama's Republican presidential rival, Sen. John McCain, had won last week's presidential election.

Mr. Obama has said he will hold drug and insurance companies "accountable for the prices they charge and the harm they cause." He has promised to allow Medicare to negotiate with drugmakers for cheaper prices, he said.

Giving Medicare the authority to negotiate drug prices - a provision that they currently don't have - would cause the pharmaceutical industry to lose $10 billion to $30 billion in annual revenues, according to a report released last month by the Boston Consulting Group.

"If you start to take a pretty big price decrease out of that large market, it has an enormous impact on drug companies and really their ability to generate their type of shareholder return that they have had in the past," said Peter Lawyer, a senior partner with Boston Consulting.

"I think [drug companies] are rightfully concerned about it. Even on the lower end of our estimate - the $10 billion - that's a big deal, that's a big chunk of your profitability."

The report analyzed the health care proposals of Mr. Obama and Mr. McCain.

With less revenue from Medicare, drug companies may begin charging more for drugs sold outside the program. And lower profits mean less money for research and development - and a reduction in the amount of new drugs on the market in the future, Mr. Lawyer said,

While Mr. Obama continues to hammer out his health care reform plan, Democrats on Capitol Hill also are working on their own proposals to overhaul the nation's medical system.

Sen. Edward M. Kennedy in recent weeks has orchestrated meetings with lobbyists and lawmakers from both parties to craft legislation to provide affordable medical coverage to all Americans.

The Massachusetts Democrat, who has been sidelined for months with a dangerous form of brain cancer, also has organized at least 14 roundtable meetings since June with members from both parties on the Senate committees with jurisdiction over health care.

Sen. Max Baucus, Montana Democrat, on Wednesday released a blueprint for universal health care coverage. His plan calls for a nationwide insurance pool that would allow those without health insurance to receive medical care.

House Energy and Commerce Chairman John D. Dingell, Michigan Democrat, whose committee has authority over health care issues, has vowed to make health care reform a priority in the coming year.

The PhRMA campaign won't be the first health care lobbying effort designed to sway public opinion against a new president's plans for health care reform. The "Harry and Louise" TV ads in 1993 attacked President Clinton's proposed health care overhaul, and were widely credited as playing a key role in killing the plan. The lobbying group Health Insurance Association of America, which ran the ads, spent $10 million on the campaign.

Drugmakers so far have generally shied away from criticizing the new administration, saying they are taking a wait-and-see approach to Mr. Obama's pending health care reforms. But the PhRMA ad campaign indicates that the industry is leaving nothing to chance.

Drug manufacturers also gave more than $1.6 million to Mr. Obama's presidential election campaign - almost triple the amount the industry gave to the Democrat's Republican rival, Mr. McCain.

"We've been moving the pieces on the chess board around for some time now getting ready for next year, and we've got a great game plan in place," Mr. Johnson said. "We think we've earned a right at the table, and we're optimistic that at the end of the day, the majority of members of Congress will recognize the importance of the pharmaceutical industry to health care."

Senate Hearing to Examine Specialty Drug Price Increases

The following meeting will discuss the 15-fold price increase of H.P. Acthar Gel (ACTH) by Questcor Pharmaceuticals as implemented in their Orphan-Drug-Style-Pricing-Model Strategy in August 2007.

I previously wrote about Questcor's new strategy (see tags on sidebar) as Acthar is indicated for the treatment of multiple sclerosis exacerbations, although the majority of MS patients use IV Solumedrol to hasten the recovery from periodic flairs. I have offered to summarize my research findings into a single post for one of the witnesses who will be speaking at the hearing.

So I've got some work to do.

SMALL MARKET DRUGS, BIG PRICE TAGS: ARE DRUG COMPANIES EXPLOITING PEOPLE WITH RARE DISEASES?

Americans Suffering From Rare Medical Conditions Also Burdened by Mounting Costs of Specialty Drugs as Pharmaceutical Companies Increase Prices Over Tenfold for Patients Undergoing Treatments for Serious Diseases Like Cancer and Epilepsy

Joint Economic Committee to Examine Sharp Price Increases for Expensive Specialized Drugs and the Impact on Consumers, Hospitals, and Care Providers

Washington, D.C. – U.S. Senator Amy Klobuchar (D-MN) will convene a hearing of the Joint Economic Committee (JEC) to examine the skyrocketing prices of certain prescription drugs and the impact on the pharmaceutical market, hospital’s budgets and patient’s medical bills. The hearing entitled, "Small Market Drugs, Big Price Tags: Are Drug Companies Exploiting People With Rare Diseases?" will be held Thursday, July 24 at 10am in Room 106 of the Dirksen Senate Office Building. Senator Charles E. Schumer, Chairman of the Joint Economic Committee, has been a staunch advocate of lower priced drugs and a competitive pricing market. The panel of experts will explore causes of recent price increases for treatments for rare diseases and the negative impact on affected families’ fiscal stability and access to care.

WHAT: Hearing: "Small Market Drugs, Big Price Tags: Are Drug Companies Exploiting People With Rare Diseases?"
WHO: Madeline Carpinelli, Institute for Pharmaceutical Research in Management and Economics at the University of Minnesota
Alan Goldbloom, CEO of Minnesota Children’s Hospital
Danielle Foltz, Parent of young patient from Rhode Island
(Additional witnesses may be added)
WHEN: 10 a.m., Thursday, July 24, 2008
WHERE: Dirksen Senate Office Building, Room 106

The Joint Economic Committee, established under the Employment Act of 1946, was created by Congress to review economic conditions and to analyze the effectiveness of economic policy.
www.jec.senate.gov

The Lucky Ones with Good Insurance Just May Become Unlucky

The New York Times recently published the article "Co-Payments for Expensive Drugs Soar" by Gina Kolata, discussing a "new pricing system" established by health insurers.

"Now Tier 4 is also showing up in insurance that people buy on their own or acquire through employers, said Dan Mendelson of Avalere Health, a research organization in Washington. It is the fastest-growing segment in private insurance, Mr. Mendelson said. Five years ago it was virtually nonexistent in private plans, he said. Now 10 percent of them have Tier 4 drug categories."

The concept of a 4-tier pharmacy benefit plan is not new and my health insurance policy has had that structure since at least 2000. As a self-employed musician, I purchase my health insurance independently, thus having an individual (non-group) policy with a well-known Blue Cross Blue Shield licensee in the Washington, D.C. area.

However, my insurance plan exposes the individual policy holder to the horrors of "cost-sharing" much further than the examples given in the NYT article. No matter the cost of medication, and no matter on which tier of the formulary the medication has been placed, my insurance coverage simply stops when the carrier's cost has reached $1500 each year. As demonstrated in the article, $1500 of pharmacy benefit would provide 75% of ONE month of the MS medication Copaxone.

See my previous post - The Value of Money or the Value of Health which should be amended to state that 1 ounce of Copaxone now costs $1900.


Reaction to the NYT article from MS Bloggers, Health Policy Wonks, and Medical Professionals:

Mandy at MS Maze - New York Times Addresses High Priced Drugs

"Although MS bloggers have been sounding the alarm for some time, we haven’t seen much in the mainstream press which addresses our concerns. It is important that we keep this issue on the front burner, especially as election time nears."

Jeri at Fingolimod and Me - Co-Payment for MS Drugs Going Sky High

"I am terrified about what will happen when this Fingolimod trial ends and I no longer get my medication for free. I strongly believe that the medicine is the reason for this long period of remission that I am enjoying, and the health care system is putting a price on that for me. I know it will be out of my reach once it has gone to market and I am forced to pay for it."

Doug at Shoester - In the News: Big Copays for MS Drugs

"Raising copays for a few sick people means many healthier people will pay less (duh), but, as a practical matter, also means the health insurance safety net is getting smaller."

Kevin, M.D. - New Tiered Pricing for Drugs

"Patients have been shielded from costs far too long, subsequently leading to an entitlement mentality. Health care is expensive, and people are starting to realize that with the emerging co-payment structure."

Peter Zavislak at Medical Pastiche - Solving Moral Hazard: Increase Copayments

"In the long-run, this will decrease prescription-healthcare costs by decreasing the incentives of moral hazard.

Out of control pharmaceutical usage-costs are part of the reason why healthcare is so expensive in this country, and a step such as increasing coinsurance rates is a good way to start reducing overall costs, in the hopes of putting more money elsewhere. It will be interesting to see what effects these changes will have in future healthcare."

From March, PhRMA statement on Prescription Sales Growth

“Ultimately, according to CMS, medicines accounted for roughly 10 percent of total health spending in the U.S. in 2006 – the same proportion as in 1960."

Vijay Goel at Consumer-Focused Healthcare - Tier 4 Copays: A Flawed Approach to Keeping a Lid on Drug Costs

"It makes sense that payers would want to check the growth in expenditures driven by specialty medications (estimates are the sector will increase from $54B in 2006 to $99B by 2010). Many of these medicines run in the thousands of dollars per month and have no generic equivalents. [see When Will We Have the Option of Generic MS Self-Injectable Drugs?]

Instead, the Tier 4 programs look to limit overall utilization of a helpful drug while not reigning in marginal pricing-- causing significant pain to the people most in need and not changing the incentives of the pharmacos."

Richard Eskow at The Sentinel Effect - Tier 4 Drugs: An Industry Response

"When plan designs are no longer made to change behavior, but simply to transfer high-cost items back to the insured party, that’s risk transfer and not benefit design. As a result, the insurance concept is being subtly modified - and arguably undermined."

Editorial in NYT - When Drug Costs Soar Beyond Reach

"The insurers say that forcing patients to pay more for unusually high-priced drugs allows them to keep down the premiums charged to everyone else. That turns the ordinary notion of insurance on its head. Instead of spreading the risks and costs across a wide pool of people to protect a smaller number of very sick patients from financial ruin, insurers are gouging the sickest patients to keep premiums down for healthier people."

Whitecoat Rants - Insurance Companies Deny More Care

"Does anyone find it interesting that the same patients who use those medications are the ones that tend to use more medical services in general? This whole Tier 4 pricing scheme is just a way for insurers to discriminate against patients with chronic disease."

Dr. Denny at Scholars & Rogues - Seriously Ill? Need Costly Drugs? Go Broke or Die

"The drugs covered by these Tier 4 and Tier 5 categories are expensive. So if these tiers charge a percentage of the cost rather than a flat co-pay, it can become ruinously expensive.

If you’re suffering from the relapsing-remitting (RRMS) form of multiple sclerosis, you may be taking Copaxone to reduce the relapse rate. The drug may cost nearly $2,000 a month. Your co-pay might have been a flat-fee $25 a month in a three-tiered plan. Under Tier 4 or 5, the co-pay may be a percentage of the whole cost.

At 25 percent of Copaxone’s cost, your co-pay could hit $500 a month (unless capped at a specific amount). That’s a life-altering 1,900 percent increase."

Mandy at MSMaze - MS and Stress Go Hand in Hand

"I have no choice in pharmacy for these precious injectable drugs. Insurance company allows but one, and they are an unpleasant group at best. They still wanted to charge me more than my maximum monthly out-of-pocket [which is $500 per script]. Interestingly, they wanted to charge even more than the previous month."

From February, Dr. Gross at Health Central - MS and Like Diseases Get Short Shrift in "Health Care" Debate

"We must have universal affordable specialty care for all patients with MS...a big-ticket item for seriously ill people, afflicted with a disorder whose onset had nothing to do with life style."

Merrill Goozner at Gooz News - High Biotech Drug Prices = A Failed Industrial Policy
[an article so great that I felt it deserved to be included here in its entirety]

"Insurance companies are charging many patients thousands of dollars a month in co-pays for very expensive drugs, the New York Times reported this morning. A quick glance of the list of drugs that the insurance industry funneled onto this so-called "Tier 4" co-pay list are recombinant proteins, products of the nation's biotech industry.

About half of the one dozen drugs highlighted in the graphic accompanying the article are made by Amgen and Genzyme, two of the nation's leading biotech companies. But rather than re-exploring the failures of these biotech industry giants, let's look at Copaxone for multiple sclerosis, which was the drug featured in the lead anecdote in the story and is made by Teva Pharmaceuticals, an Israeli company whose original claim to fame was as a maker of low-cost generics.

From the FDA Orange Book, we learn that the Food and Drug Administration approved this drug in 1996. From the nation's public registry of clinical trials, we learn that the primary approval trial for Copaxone (copolymer 1, a combination of four recombinant proteins) involved about 250 patients with relapsing MS, half of whom were randomized to placebo.
This trial, according to the government, was conducted at the University of Maryland on a National Institutes of Health grant with information provided by the Office of Rare Diseases at the Food and Drug Administration. In other words, taxpayers like you and me paid for the seminal research that brought this drug to market.

According to this website produced by a Brit with MS, we learn that Copaxone reduced the rate of relapses among patients taking the drug by about 29 percent. Subsequent trials, funded by Teva, showed that it was slightly superior or equal to the other drugs for the condition that are on the market (Betaseron by Bayer and Avonex by Biogen, both of which are recombinant forms of interferon). Most of these trials involved just a few hundred patients, and often did not have the statistical power to prove anything in these head-to-head comparisons.
Teva continues to fund research. Again, a quick glance at Clinicaltrials.gov suggests most of these trials compare Copaxone to other drugs for the condition. There are also a few companies seeking to get approval for their own brands of interferon to fight MS, undoubtedly attracted by the high prices set on Copaxone. The government is also still involved. The National Institute of Neurological Diseases and Stroke (NINDS) has financed Dr. Fred Lublin of Mt. Sinai Medical School to test 1,000 patients randomized to either Copaxone, Avonex or placebo. Unfortunately, that trial, which began in 2005, won't be completed until 2012, just two years before Copaxone goes off patent.

Now let's follow the money. A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients.

The only justification for the high prices slapped on this government-funded discovery is that it would generate research into new drugs and significant therapeutic insights. Consumers, who paid the tab through their insurance premiums, got neither for their investment. And the government, which could have used that money and much less of it to get started earlier in funding definitive trials, now must come with another huge infusion of cash (a 1,000-person trial will cost at least $10 million) to sort out the mess.

In 1991, when then Secretary of Health and Human Services Louis Sullivan was hauled before Congress to explain why it was paying so much money through the Medicare program for Amgen's Epogen, which is used in dialysis patients, he testified that it was to show Wall Street that this new exciting industry -- biotechnology -- would generate generous returns if it came up with innovative products. Isn't it time to call a halt to this failed industrial policy, especially when it comes to drugs brought to market with taxpayer support? Surely the patients like those now paying 25 percent of the cost these drugs in Tier 4 co-payments deserve better."

Yes, I agree. We all deserve much better.

Drink Up, Drug Up, Read Up

I simply love the reaction to the MS Blogger Project which is continuing to reach out over the globe. So many kind folks have reposted the long list of links to bloggers out there who just happen to be touched by MS in one way or another. In fact, I'm still tracking down folks who I initially missed in the round up. So please, if you know of others not included, do let me know. And if you are reluctant to post the entire list, please consider sending folks here to Brass and Ivory to check it out.

Also, just a reminder that submissions for this week's Carnival of MS Bloggers are due tomorrow. Please submit a post (via blogcarnival or email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, March 11, 2008.

Now on to the business of this brief post regarding levels of pharmaceuticals found in drinking water. As you may have read, the Associated Press released information regarding investigations into the level of pharmaceuticals found in our drinking water.

Here is a little of what is being said today around the blogosphere:

AP Probe Finds Drugs in Drinking Water - Associated Press Writers
Big Pharma Is in the Water - Sarah Rubenstein of the WSJ Health Blog
Drugs in the Water Supply - Dr. Val Jones of Revolution Health Blog
Until You Get Your Metabolism in Line, We Will Never Have Clean Drinking Water - PharmaFraud Blog
PhRMA Statement on Pharmaceuticals in the Environment - Ken Johnson

Normally, I would never flush drugs down the toilet, but considering that tomorrow will be the fourth of a 5-day IV Solumedrol treatment, I guess I don't really have a choice in the matter. What goes in must come out...

In Honor of the Academy Awards - Oscar Night for SiCKO

SiCKO has been nominated for Best Documentary Feature in the 80th Annual Academy Awards, show airing February 24, 2008. Rather than discuss the American healthcare system and all of it's deficiencies, I'd like to share a story with you.

In November 2006, I met a kind, respectful, and very intelligent person named Meghan O'Hara. Meghan happens to be producer of SiCKO and had come to my music studio for an on-camera interview.


This is Meghan, her film crew, and me.

Francisco Latorre, production sound

Peter Nelson, camera

Meghan O'Hara, producer

Lisa Emrich, at the piano

Christine Fall, field producer
(not present)

How in the world did I meet Meghan and her film crew you ask?

Well, after being diagnosed with multiple sclerosis, I encountered some difficulty in receiving and paying for the medical treatment I required - and this while being 'fully' insured. I had been put through the ringer by several programs which propose to help uninsured and under-insured patients pay for and obtain their medications or which focus on multiple sclerosis.

By the summer 2006, I had approached and/or applied to programs offered by (or previously offered by) the following organizations:

• Shared Solutions (refers patients to NORD)
• National Organization for Rare Disorders
• National Multiple Sclerosis Society (no money for meds)
• Multiple Sclerosis Society of America (no money for meds)
• Multiple Sclerosis Foundation (no money for meds)
• Patient Advocate Foundation
• Patient Access Network Foundation
• PAF Co-Pay Relief Program (no longer has MS fund)
• Patient Services Incorporated (no longer has MS fund)

And since that time, I have also had interactions with the following:

• Cephalon - Provigil Assistance Program
• National Organization for Rare Disorders
• Partnership for Prescription Assistance
• HealthWell Foundation
• Chronic Disease Fund
• Pfizer Connection to Care
• Rx Outreach

So it was due to struggling with 'the system' and being 'rejected and denied appeals' to obtain the necessary assistance that a friend of mine passed on an email she had received from an organization she is a member of in the mental health field. The email was an appeal for real life stories for a documentary which Michael Moore was filming on the American healthcare system.

His production company was looking for 3 real people who fit certain criteria to feature in his movie SiCKO. My real-life situation fit the requirements - and I thought to myself "why not" - so I spent an hour or so that afternoon and composed a lengthy email detailing my situation, my struggles, and the numerous insufficient outcomes. I pressed the send button although I had never seen a Michael Moore film before.

Less than 2 weeks later, I received a phone call from Christine Fall, a field producer of Michael Moore's production company. Apparently, my email had grabbed someone's attention and found it's way to Christine's desk for further investigation. We spoke on the phone many times over a couple of months with her asking questions related to what I had shared in my email, follow-up questions from our talks which her colleagues wanted asked, and questions related to other experiences and thoughts I had about certain things (including the Big Orange 'Help is Here' Bus.)

Eventually we worked up to the big question -

"Would you be willing to be interviewed on camera?" I said yes.

So in November 2006, on a rainy Thursday evening, a film crew came to my music studio to interview me regarding my experiences with the 'heathcare system' and to see me in action with a student or two. Of course, I had to okay it with the student and his/her family beforehand.

I had never spoken with Meghan before and we did not discuss any of the questions she would ask beforehand. That way what was caught on camera was non-rehearsed and organic. My mother watched the monitor for those several hours and later said that I was very impressive on camera - calm, articulate, compelling. The interview lasted much longer than Meghan or I had anticipated, likely due to my charismatic nature (hehe).

During the interview itself, I didn't crack a tear or resort to showing the piles of bills, explanation of benefit statements, or rejections from various programs. I spoke the truth, clearly and honestly, without great drama or pretense. I even shared my discoveries regarding Cephalon's deal with TEVA regarding Provigil.

A month or so before the Washington, D.C., premiere of SiCKO, I received a call from Rehya Young (associate producer) informing me that my scenes had been cut from the film, although there were those who fought to keep them in. But who knows why editors make the decisions they do, otherwise one of the major difficulties which MS patients face, being expensive pharmaceuticals and financial security, would have been placed on screen for the world to see. Oh well - a missed opportunity.

I was invited to attend the DC premiere which I did in June 2007 as Mr. Moore's guest. Outside the theater, several reporters from local papers were looking for folks involved with the film to interview. My mom got someone's attention to see if he would like to interview me. The question first asked was, "Were you one of those who went to Cuba?" Well, no. "Not interested, sorry."

Media only wants the "stars." Another missed opportunity.

I did enjoy the movie and afterwards met Meghan in the lobby of the theater. She recognized me immediately and apologized for cutting my scenes. We talked for a while and she asked if I had met Michael. I had not.

I stayed around until the crowd dispersed, leaving only a smaller entourage. Meghan introduced me to Michael and his first words were, "you're the horn teacher!"

"I'm sorry we had to cut your scenes."

He told me that he had asked the British pharmacist about the cost for filling my prescriptions in England. (If you saw the film, you know what this refers to.)

And that maybe....include on the DVD....

But they're not - a final missed opportunity.

However, my name is included in the credits, right below Danny Elfmann.

I'll be watching and will cheer if SiCKO wins the award.

Remove Financial Disincentives and Increase Prescription Compliance

Don't you enjoy reading something and going...."Yes! Of course!"

Besides the 'well, duh' reaction to a study published in the January/February issue of Health Affairs, I think those interested in healthcare reform should examine what exactly is being measured here.

The study was led by researchers at University of Michigan and Harvard University. The study was funded by GlaxoSmithKline and Pfizer, and was conducted in part by ActiveHealth, an Aetna subsidiary that designs the kind of plans discussed.

At the University of Michigan, the Center for Value-Based Insurance Design was established in 2005 "to develop, evaluate, and promote value-based insurance initiatives that achieve improvements in health outcomes and contain health care costs."

Value-based insurance design offers a potential solution to the health care financing crisis. Value – the clinical benefit achieved for the money spent – is absent from the current dialogue on how to solve the health care dilemma. Instead, the dialogue focuses on two trends in benefit design – cost containment and quality improvement – which create a conflict of incentives for patients.

Money is a huge motivator in American society. We work for money, we worry about money, we manage our money, we spend our money, we save our money, we fight over money, we often measure something's importance by it's monetary value. Money, money, money....

Insurance companies and large employers are spending increasing amounts of money in disease management services, in part, to help them limit future costs and ultimately save money.

The study in question sought to measure the impact of offering lower drug co-payments to people with diabetes, high blood pressure and other chronic diseases on the increased use of preventive medicines. Higher co-pays are frequently used by American employers to cope with the rising costs of health insurance and require workers and retirees to pay more out of their own pockets. But does this is ultimately help patients and save money for the employer in the long run?

Proper treatment for a number of chronic illnesses can be very effective at preventing complications of disease and can help patients stay physically active and productive employees. But that treatment is only as good as when the patient stays compliant with therapy. That means the patients needs to take the recommended medication on the recommended dosing schedule.

The study compared two companies, one of which cut employees’ co-payments on a few key drugs, such as statins for cholesterol and beta blockers for high blood pressure. Generics were free to employees, and the co-pays for branded drugs were cut in half. Cutting co-pays reduced non-adherence by 7-14%.

[E]mployers increasingly enroll beneficiaries in expensive disease management programs designed to improve patient self-management, often by intervening to enhance compliance with specific medications. However, at the same time, rising copayments and greater cost-sharing create financial barriers that discourage the use of recommended services. When patients are required to pay more for their health care, it is well known that they buy less – of both essential and excessive therapies alike.

"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."

Many companies are already paying for disease management programs to help patients with chronic diseases such as diabetes. So why not encourage people to take the medicines they need. You “pay a nurse $65 an hour to call call a diabetic [employee] and say, ‘Take a beta blocker.’ And the employee says ‘I know it’s important, why did you raise my copay from $15 to $30,” Fendrick says. “It’s a classic example of the misalignment of incentives in the U.S. health care system.”

In response to the report on the WSJ Health Blog, I commented:

Lower copays is a nice idea, but how about requiring insurance companies to cover disease-modifying meds under major medical instead of pharmacy benefits. Or not allowing insurance companies, such as the local Carefirst BCBS in DC, to establish an annual $1500 limit for drug benefits in their individual policies. The Carefirst policy I’ve had for over 7 years has maintained the same $1500 cap for drug benefits. However, the initial wording of my policy implied that a 10% coinsurance would apply after the limit was reached, but that has not not been the case. $1500 covers only 3.5 weeks (25 days) of my MS med, much less any other of the meds I take for Rheumatoid Arthritis or Hypothyroidism, each drug which works to limit damage and allow me to stay active. Preventing further damage and staying active seem pretty important to me. It’s just unfortunate that my copays for meds end up being about $25,000 each year after insurance has paid their ’share.’

And reader Tom responded:

Lisa’s case typifies what really needs repairing in the health care system. This incidentally, is why there is public outrage directed at pharmaceutical companies that is totally unjustified. The culprit is and has been insurance companies. Remember, they are the entity that the Federal Government uses to administrate Medicare. Employers and employees pay for their coverage, it is not gratuitous. The companies then “decide” what they will pay for. Does the term “racket” edge to the forefront? Give us all your money, but we really don’t want to pay anything out. THIS is the mantra that needs addressed.

After a lively discussion, reader CR concluded:

…getting back to the actual article to which this exchange is attached… I would simply point out that, while Fendrick’s mother is right about the “duh” factor in his studies, the notion of aligning co-payments to achieve treatment objectives is a benefit design innovation. Further, it’s important to note that it was not an innovation that came out of academia or the government, but large employers. Pitney Bowes took the lead in creating, evaluating and reporting results of this value-driven approach, which was first given wide report in WSJ in May of 2004. Fueled by ongoing additional research efforts by Fendrick and others, the concept continues to be refined. Point is, employers–seeking better value from the health care supply chain–innovate solutions that would never be conceived of by bureaucrats.

The innovative idea of connecting copays to compliance and health outcomes is a smart benefit design. If only patients were valued not by their costs to the system, but by their positive health outcomes contributing to the overall economic system.

And finally Peter Pitts commented on his blog : Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.

Amen Peter.

Misguided Attempt at Influencing Patient and Political Behavior

So Kevin, M.D., applauds the great idea that physicians use big-screen TVs in their waiting rooms to warn and educate patients on the impending physician shortage, as well as educating the public on the malpractice crisis.

He refers to an article in The New York Sun -- "Captive Audience: MDs Fighting Back on Malpractice" by staff writer E.B.Solomont. So like any responsible reader, I followed the link to the original article.

Fed up with the state's medical malpractice insurance crisis, some New York City doctors are airing televised messages in their waiting rooms that warn patients of a looming physician shortage.

One 60-second spot describes a scarcity of radiologists in the Bronx who are willing to perform mammograms because liability costs are too high. The message aims to change the way patients think about malpractice, doctors said, adding that by airing the advertisements they aim to shore up legislative support, and to inform patients that higher insurance costs could mean they'll have to pay higher fees.

"I don't think it's going to keep anyone from suing, but I think
the public has to know where the health care dollars are going," a Manhattan internist, Dr. Margaret Lewin, said. "My objective is to educate the patient as to what's going on politically, so if they can join us in making some changes that would be terrific," Dr. Lewin, who is president of the New York County Medical Society, said.

So far, more than 100 offices in Manhattan and in the Bronx have been outfitted with $4,000, 40-inch television sets that were donated to members of New York's medical societies by a Long Island company, MedLink International. The company also sells products such as electronic health records.

Forget the idea of malpractice for just a moment. Why is a healthcare IT company donating large flat-screen TVs for use in physicians' waiting rooms?

On December 6, 2007, MedLink International, Inc. announced that the Bronx County Medical Society ("BCMS") has officially endorsed MedLink International and its products and services, including MedLink TV.

More than 800 physician members of BCMS will be offered MedLink TV as a benefit of membership with the New York County Medical Society.

BCMS members will receive the 40" flat-screen MedLink TV for free, as long as they are in good standing with the BCMS. Physicians can sign up for the service at http://www.medlinktv.com/, in addition to finding out more information about the program.

MedLink TV, a partnership between MedLink and DynaTek Media, in cooperation with industry leading physicians, strives to provide patients with thought-provoking, entertaining and informative healthcare related programming. Physician members of BCMS, by supporting MedLink TV and providing this programming in their waiting rooms, are encouraging thoughtful communication between patients and healthcare providers, with the goal of providing the very best in healthcare for their patients and their families.

This announcement followed on the coattails of the October 15, 2007 announcement in which the New York County Medical Society ("NYCMS") officially endorsed MedLink International's MedLink TV.

More than 8,000 physicians in Manhattan will be offered MedLink TV as a benefit of membership with the New York County Medical Society.

MedLink representatives recently met with NYCMS in September to discuss MedLink offerings that can be a benefit to the Society's members. After careful consideration, the Executive Committee of NYCMS voted to endorse MedLink TV.NYCMS members will receive the 40" flat-screen MedLink TV, a more than $5,000 value, for free as long as they are in good standing with the NYCMS. Physicians can sign up for the service at http://www.medlinktv.com/, in addition to finding out more information about the program.

On August 16, 2007, MedLink International, Inc. formally announced the signing of a consulting agreement with the leading healthcare law firm of Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato & Einiger.

The affiliation will be spearheaded by one of the firms Senior Partners, Scott Einiger, general counsel to The New York County Medical Society.

Medlink CEO Ray Vuono states “We have established this strategic alliance with the preeminent Healthcare Law firm in New York State, one that has a longstanding relationship with organized medicine, hospitals and nursing homes. We at MedLink are extremely pleased to have entered into this new relationship as we continue our efforts to bring our simple, secure and affordable electronic medical record and practice management solutions to the medical community nationwide.” said CEO of Medlink Ray Vuono.

Through his 20 years as a healthcare legal advocate, Mr. Einiger has worked extensively with medical societies associations, and organizations. In addition to Mr Einiger, Gary Gatza will be bringing his many years of experience to the relationship. Mr. Gatza has practiced law for over 25 years and prior to joining Abrams, Fensterman, he served as General Counsel and Executive Director of the New York County Medical Society.

Mr. Einiger stated “MedLink has expressed a true desire to partner with and support organized medicine while providing practicing physicians with the tools to succeed in an extremely competitive environment. MedLink’s cutting edge technology provides an extremely cost effective solution for the practicing physician. Health care consumers will also receive a tremendous benefit from MedLink TV, a healthcare network that provides relevant healthcare programming right in the physicians waiting area”.

Scott Einiger is senior partner and director of the New York City Health law practice at Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato, & Einiger, LLP. Mr. Einiger has extensive experience in healthcare law. A leader in his field, Mr. Einiger is Special Counsel to The New York County Medical Society and General Counsel to The American Academy of Psychoanalysis. He has recently been named counsel to the New York Society of Gastroenterology. He was also part of a comprehensive risk management/quality assurance program designed to reduce liability risks for health care professionals and hospitals insured with the Medical liability Mutual Insurance Company, where he was counsel for 15 years.

Abrams, Fensterman, et al. is one of the largest health care law practices in New York State representing their clients in a variety of complex health care related matters. "Our health care lawyers understand the demands of the market and have broad legal experience with a wide range of issues facing our valued clients."

Back to MedLinkTV where patients will be exposed to 60-second spots warning of the dangers in the rising malpractice crisis and the looming doom of physician shortages at least once during each half hour.

On March 21, 2007, MedLink International, Inc. announced that it...

...has expanded its relationship with DynaTek Media Corporation to form MedLinkTV, which will deliver content and advertising to a digital screen network in the waiting rooms of physician offices and outpatient clinics.

Ray Vuono, CEO of MedLink, stated that, "MedLink is very excited to provide patients with informative health care information through MedLinkTV LLC, which we have formed with DynaTek Media, our content delivery partner. DynaTek will provide and deliver entertaining health-based information and advertising from pharmaceutical companies and consumer product companies to the consumer while they wait for procedures and examinations."

Mr. Vuono continued, "MedLinkTV LLC offers advertisers a captive audience of viewers who can be reached through targeted messaging. Consumers will be in an environment where they will be receptive to hearing about health and wellness issues, and products that can enhance their wellbeing and lifestyles."

Ron Gross, CEO of DynaTek Media, Inc., added that, "DynaTek is looking forward to deploying MedLinkTV, which will ultimately be able to bring product information to consumers, ranging from prescription drugs to over the counter items, such as headache and allergy remedies, as well as informative content that promotes health and wellness. MedLink TV content will help make the patient experience during doctor and clinic visits a more positive one for consumers."

Now we're finally getting to the heart of the matter, the root of the problem, and the motivation behind the education being offered....product placement and advertising.

I went to the DynaTek Media website and watched some examples of their work. Their MedLinkTV demonstration certainly looked like a 'fake news' report accompanied by commercial advertising.

In the New York Sun article, public service announcements created from news broadcasts were mentioned.

"We want patients to begin to think about the potential in the future for them, that their physician may not be able to afford to be in practice," the president of the Medical Society of the State of New York, Dr. Robert Goldberg, said.

The doctor of osteopathic medicine said he has several colleagues who are no longer able to afford their insurance premiums. "This is very real," he said. "There are ramifications to the frequency and severity of these lawsuits," he said. "One of them is, will there be a doctor to take care of you?"

In one public service announcement, which was adapted from a news broadcast in Oregon, a woman is forced to drive several hours to see an obstetrician because of a shortage of doctors in her town.

Now you can ask me, but probably can already guess my opinion.

Did the Oregon news broadcast truly arise from relevant news in that particular locale or was it produced merely for it's future propaganda value?

DC Council takes first step to clipping the wings of the pharmaceutical industry

Today's Washington Post reports a bold move by the D.C. Council to regulate pharma reps who peddle drugs to District physicians and hospitals. The SafeRx Act of 2007 breaks new ground in the effort to reel in the multibillion-dollar prescription drug trade. Below are highlights from the must-read article.

The D.C. Council voted 7 to 6 yesterday to give initial approval to legislation that would make the District the first jurisdiction in the country to license pharmaceutical sales representatives, a major blow to the prescription drug industry and one that could have national implications if states follow the District's lead.

"For too long, we have allowed profit and paternalism to be our guide for patient safety," said Council member David A. Catania (I-At Large), who has become known in national health circles as an industry watchdog. "The truth is, no one is minding the store."

After the vote, Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, issued a statement through spokesman Jeff Trewhitt.

"We regret that the council voted in favor of legislation that creates unnecessary financial burdens for the District of Columbia at a time when the money would be better spent addressing a wide array of health care challenges confronting the city including HIV/AIDS, diabetes and heart disease," the
statement said. "The bill passed by the council puts the city into a regulatory arena that has been effectively addressed by federal laws and federal government agencies for years."

Under the bill, salespeople would have to be licensed and sign a code of ethics and would be regulated by a pharmacy board. To qualify for a license, the representatives, dubbed "detailers" in industry lingo, would have to be college graduates. They would also have to refrain from using titles that would give the impression that they are licensed to practice pharmacy, nursing or medicine.

The bill, which has several parts, also would ban pharmaceutical manufacturers from engaging in a practice called "data mining," when doctors' prescription data are used for marketing purposes without their knowledge and consent.

Critics say the information trickles down to detailers who can then target a doctor for a particular drug by looking at his or her prescribing habits. District doctors could opt in to the program to allow firms to get their prescription data from pharmacies.

New Hampshire, Maine and Vermont, which have passed similar legislation, are in court with data collection companies and manufacturers fighting the new laws. New Hampshire is appealing the decision of a U.S. District Court judge to block the state from enforcing its new data mining law on the grounds that it restricts commercial free speech.

The District could face the same fight, council members said.

Catania said that is to be expected. "They are taking their playbook from the tobacco industry," he said. "Sue, sue, sue."

Yesterday's vote, however, will not end the debate. The council must vote again Jan. 8 on final approval of the legislation.

Generic Biotech Drugs -- The House Energy and Commerce Committee meeting to consider establishing a Regulatory Pathway for Follow-On Biologic Drugs

"The Access to Life-Saving Medicine Act — introduced by Congressman Henry Waxman (CA) — would provide a statutory pathway for the Food and Drug Administration (FDA) to review and approve generic biologic therapies."

The cost of biological multiple sclerosis treatments — $16,500 to $29,000 each year — can unfortunately force many people to stop their prescribed therapy because they just cannot afford it. More affordable, generic options for this fast-growing and expensive category of drugs are not yet available. Many people living with MS and other diseases depend on biological drugs to sustain or improve their quality of life. For MS, those therapies include Avonex, Betaseron, Copaxone, Novantrone, Rebif, and Tysabri.

It is the case too often that prescription assistance programs are insufficiently funded, have extremely strict eligibility requirements, or simply do not offer assistance for these biologic drugs due to the extreme cost. Listen to a recent NPR broadcast on this issue (transcript provided below). It includes the story of Donna Gosbee of Wyoming who lives with MS and her struggle to afford therapy.

Biologic (also known as biological or biotech) drugs are produced from living cell cultures rather than synthesized chemically. The generic drugs that are currently available are synthetically exact copies of the brand name original, based on a precise chemical composition. Generic versions of biologic drugs, on the other hand, would need to allow for nuances in the cell cultures while meeting certain parameters that are strict enough to ensure they are just as safe and effective as the originals.

The U.S. Senate has passed legislation that would establish a course for approving safe, effective, affordable, and comparable versions of biologic therapies for MS and other diseases. Unfortunately, the House still has not yet taken up a similar bill. Members of the House of Representatives will be meeting this month to talk about creating a pathway for the approval of follow-on biological drugs. Reports indicate that members of the House Energy and Commerce Committee will meet on October 31 to discuss the issue.

It is imperative that the House Energy and Commerce Committee take action on this bill, where Congressman John Dingell (MI) and the rest of the committee will help shape the final legislation. The time for Congress to take action is now. The Access to Life-Saving Medicine Act — introduced by Congressman Henry Waxman (CA) — would provide a statutory pathway for the Food and Drug Administration (FDA) to review and approve generic biologic therapies.

Take a minute to write your Representative today. Ask them to move forward with the Access to Life-Saving Medicine Act (H.R. 1038). Congress can provide the FDA with a pathway for approving safe, effective, and lower-cost versions of biologic drugs. And give people living with MS and other diseases more affordable options for therapy.

~~~

History of the Access to Life-Saving Medicine Act (H.R.1038)

On February 14, 2007, Rep. Waxman, Rep. Jo Ann Emerson, and Rep. Frank Pallone, Jr., along with Senators Charles E. Schumer and Hillary Rodham Clinton introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. Other original co-sponsors are Reps. Rahm Emanuel and Mazie Hirono, and Senators David Vitter, Susan M. Collins, Patrick J. Leahy, and Debbie Stabenow. Biotech drugs, which are produced from living cell cultures rather than synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill. Currently there is no statutory pathway for biotech drugs, and manufacturers of biotech drugs can charge monopoly prices, indefinitely.

Generic drugs (first made possible under the 1984 Hatch-Waxman Amendments) have been extremely successful in bringing down the high cost of prescription drugs. Generic drugs save patients and payers $10 billion a year. But there is no generic competition for one of the fastest growing and most expensive category of drugs: so-called biotech drugs, also known as biological drugs or biopharmaceuticals. It is common for these drugs to cost tens of thousands of dollars a year, even after patent expiration. Many patients are now denied access to these important drugs because even the co-payments can reach thousands of dollars a year. And the sky-rocketing cost of biotech medicines is imposing increasing burdens on employers, insurers, and the federal government. Introducing fair competition for biotech drugs is essential to keep these life-saving treatments affordable.
Press Release - Rep. Waxman's Statement - Background on Biologics - Bill Summary - Quick Summary - Bill Text - Letters of Support

~~~

NPR Health & Science: All Things Considered, August 9, 2007

Are Generic Biotech Drugs Coming Soon?
by Joanne Silberner

Correction: At the time this story aired neither the House nor Senate had voted on legislation. There have been two hearings in subcommittees of the House of Representatives, and a Senate committee has approved legislation.

All Things Considered, August 9, 2007 · While Congress is away this month, House and Senate staffers are working on a bill aimed at helping patients who rely on innovative biotech drugs that can cost as much as several thousand dollars per month.

Generic versions of the drugs would surely be cheaper, but opponents of generic versions say that making sure the knockoffs are safe and effective may be trickier than it sounds.

Donna Gosbee, 51, came from Wyoming to Washington, D.C., to attend a meeting of the Multiple Sclerosis Society. She is using a walker.

"I never know from one day to the next until I put my feet down on the floor whether I'm going to be able to walk," Gosbee says.

Gosbee was diagnosed with multiple sclerosis four years ago.

"The doctors put me on one of the biologics, Betaseron," she says. "I've been on it for three years now and this drug costs $1,500 a month."

The government helps Gosbee with some of the cost, but she's worried the help won't always be there. So she came to Washington to lobby Congress.

Lobbying for Change

"I'm going to talk to Wyoming legislators to try to convince them that medications are just out of reach of the normal person," Gosbee says.

A generic could significantly cut her medical bill. At www.drugstore.com, for example, the generic version of the statin drug, Mevacor, is only one-third of Mevacor's price.

But Gosbee's drug is manufactured very differently — by living, bioengineered cells.

They make molecules that are much bigger than most conventional drugs, and a lot more complex, says Roger Williams, CEO of U.S. Pharmacopeia, a nonprofit organization that sets standards for drug manufacturers.

"If I showed you on a page the molecular structure of a biologic, it might cover two pages just of carbons and nitrogens and hydrogens and oxygens," Williams says.

In contrast, he says the structure of many conventional drugs fill less than half a page.

Williams says making conventional drugs is like snapping together Tinker Toys. You add one chemical after another, and the manufacturer is very much in control.

Making a biotech drug is more like farming. You start with a living cell, then keep the temperature, the nutrients and other growing conditions just right. Just as wheat grown from a different seed stock or under different conditions will produce slightly different grain, different versions of biotech drugs can vary — even when made by the same company.

The Process of Biotech

In Gaithersburg, Md., a company called MedImmune makes the biotech drug Synagis. The drug fights a virus called RSV that can kill premature babies.

Just getting into MedImmune takes work — you have to put on gloves, booties and a double set of what look like surgical scrubs.

You must also go through multiple airlocks. Sterility is important for conventional drugs, too, but it's especially important here. If bacteria or viruses get into the cell cultures, they could disrupt the manufacturing process and wind up in the final drug.

Workers take large beakers of living cells in culture from a refrigerator. The cells go into gleaming metal vats the size of small cars.

"This is the start of our bioreactor train," explains Tony Luttrell, MedImmune's vice president.

There are enough pressure monitors and temperature gauges and pipes to make a science-fiction movie proud.

Conventional manufacturers use temperature gauges too, as well as vats filled with buckets of chemicals.

But these biotech vats hold mouse cells, each one loaded up with human DNA. The human DNA is directing the cells to produce a particular protein — an antibody that can fight RSV.

If you want to make a copy of MedImmune's drug, you would have to insert some human DNA into mouse cells in a precise way — a way that will produce that protein. It's a real challenge.

"One little genetic change, one little change in the way the protein is configured or the way the proteins fold onto each other may have an effect on how it actually acts in the clinic," Luttrell says.

Then you have to be really careful about how you grow the cells, Williams says. For example, temperature can make a big difference. Look at albumen — the protein in egg whites.

"If you take egg white and cook it, that's OK to eat, but it's no good to the chicken anymore," Williams says.

Generic Outlook

Williams thinks some biotech drugs could be made generically. But the only way to know for sure that a different version would be just as safe and effective is to perform lengthy and expensive testing in animals or people — something that's not required for conventional generics.

There have been two hearings in subcommittees of the House of Represenatives, and a Senate committee has approved legislation. Staffers are now working to develop legislation that can win approval.

But don't hold your breath — companies that make brand name drugs are still adamant that testing in people should be required.

Patients and generic companies waiting for less expensive drugs aren't happy either. Both bills would make generic companies wait 12 years before they could market a cheaper drug, not much different from conventional generics, but a long time when you're spending several thousand dollars a month to fill a prescription.

Copyright 2007 NPR

Who spent $83,959,239 in 6 months to 'educate' policy-makers and the public!!

If you answered Big Pharma and Associates, you're Right!!

Special thanks go to the Lobbying Disclosure Act of 1995 which allows public access to records of lobbying activity on Capitol Hill.

Between January 1, 2007 and June 30, 2007, Pharmaceutical Research and Manufacturers of America (PhRMA) invested at least $13,213,600 in congressional lobbying efforts, $2,525,000 of which was expended through outside firms on PhRMA's behalf. That's an expensive average $2,202,800 per month for "winning advocacy for public policies..."

Independently, PhRMA member companies spent an additional $67,954,211 during the same time period. Other organizations (ie. pharmaceutical companies, professional associations, county health departments, hospitals, universities, and special interest groups), not directly affiliated with PhRMA, spent $2,793,428 on congressional lobbying. These interested parties monitor healthcare issues, seek to educate officials, and influence legislation regarding Medicare , S-CHIP, drug importation, drug-price negotiation, intellectual property rights, government appropriations, health information technology, and healthcare reform, to name a few issues.

Total spent: $83,959,239



So what's the Return-On-Investment?

Obviously, investment in public policy must be financially advantageous for corporations and their stockholders, otherwise resources would be put to work elsewhere. We often hear how CEOs of the big pharmaceutical companies or of the health insurance corporations are making millions of dollars each year for overseeing these profitable businesses. The business of Health Care in America must be thriving with so much financial influence to fling around.

Profit!!!

That's what the American free-market is all about...profit. If an entity is profitable, it is deemed successful and becomes a magnet for investors, which then helps the original entity be more successful and thus more profitable. The cycle is vicious and unrelenting...so much so that public policies are often influenced by successful businesses, or industries, in an attempt to shape the rules of play, stacking the deck in their favor, and preserving opportunities to increase profitability.

Increasingly, elected and appointed officials who are the architects of the playing field and authors of the playbook leave public service to join the game. For a blatant example of public service leading to personal wealth, one only has to look to former U.S. Rep. Billy Tauzin who now heads PhRMA. As Chairman of the House Committee on Energy and Commerce (HCEC), Tauzin was instrumental in getting the Medicare Drug Act of 2003 passed which increased the role of private insurance in providing drug coverage to medicare beneficiaries while prohibiting government from participating in free-market tactics of negotiating prices.

Before Tauzin officially took the reins of PhRMA, Public Citizen commented on the turn of events in a Dec 2004 report, Washington's "Revolving Door" is Spinning Out of Control. "The selection of outgoing U.S. Rep. Billy Tauzin (R-La.) to be president of the pharmaceutical industry’s main lobbying group is yet another example of how public service is leading to private riches, Public Citizen said today."

~~~

Another example of Washington's "Revolving Door" can be found in a new private equity fund, Health Evolution Partners. On June 7, 2007, The New York Times published an article, "Venture Fund to Seek Out Cost Cutters in Health Care," by Steve Lohr. Dr. David J. Brailer, a former senior health official in the Bush administration, founded Health Evolution Partners, with an initial investment of $700,000,000 from CalPERS (California Public Employees' Retirement System).

Read the June 5, 2007 Press Release. To accomplish the goal of "realizing value in health care," Health Evolution Partners "brings together financial capital with deep industry know-how to help companies improve their business strategies, achieve large-scale commercial success and set new benchmarks for financial performance."

More on Dr. Bailer coming soon.

~~~

Commercial Success and Financial Performance

That's truly what is driving health care in America...MONEY!! As long as profit is the driver, concern for the health and security of American citizens will be secondary at best.

Physical Health, Emotional Health, Financial Health

Weakness in one too often causes weakness in all!!!