Are we hostage to pharmaceutical industry

From the dictionary: hos·tage Pronunciation: \ˈhäs-tij\
Function: noun
Etymology: Middle English, from Anglo-French, from hoste
Date: 13th century
definition: a person held by one party in a conflict as a pledge pending the fulfillment of an agreement

In our previous blog, we questioned what the pharmaceutical industry might be getting from its 'cooperation' in reducing prices for seniors in the Part D Doughnut Hole. In his AARP 'Town Hall Meeting' July 28, President Obama seemed to indicate that while he believed that we could lower prices even more, he failed to explain how. Then he explained how without 'negotiating' with PhRMA, the industry's trade association, the drug manufacturers would 'fight' for every 'cent of profit' they are making...and could make.

What a regrettable state of affairs, an Administration and the U.S. Congress being held hostage by what arguably is the most powerful industry in the world. Unless reform is passed that further enriches the pharmaceutical industry, it will fight reform.

This leads us to ask what other tactics will pharma resort to if it doesn't get its way. And, what price will there be for its 'cooperation'? Already, price negotiation for prescription drugs, and personal importation of medicines from Tier One countries seem to have been kicked to the curb. But the fact remains: There is a proven record of safety and efficacy, as well as affordability of imported medicines providing vital medicines to Americans. Is restricting the ability of those untold numbers of Americans to purchase safe, affordable medicines from pharmacies in Tier One countries to be next, making it a clean sweep for pharma? The U.S. Congress has previously voted to end such questionable activity and most recently, Senator David Vitter (R-LA)has been successful with his introduction of legislation to prohibit such seizures for the next fiscal year. The chances of this being coming out of conference is uncertain. The Senator's office has declined to respond to inquiries about the amendment's prospects, but should it not be retained, the question must be asked, why. This is a legitimate question in light of pharma's success on a number of fronts, all the while claiming to exhibit a spirit of concern about what it does to lower prescription drug prices for Americans (the highest in the world), while holding a club of the threat of higher prices and withdrawal of its 'cooperation' in reaching an agreement.

Excerpts from the President's remarks follow:

Excerpt from opening remarks:

"...And I think for AARP members especially there are hundreds of thousands of people out there who would directly benefit from reduced prescription drug costs if we're able to pass this bill.
And we'll work to close that doughnut hole in Medicare Part D that's costing so many folks so much money. Drug companies, as a consequence of our reform efforts, have already agreed to provide deeply discounted drugs, which will mean thousands of dollars in savings for the millions of seniors paying full price when they can least afford it..."

In response to a question:


Q Hi, this is my first year in the doughnut hole, and it's quite a frightening thing to go through. I have Parkison's so I will be going through it year after year, and it looks like I could last about two years, and then all of my savings will be gone to the doughnut hole. So what do you intend to replace the doughnut hole with?

THE PRESIDENT: Well, we want to replace it with prescription drugs that won't force you to use up all your retirement.

When the original Medicare Part D was put forward -- first of all, it wasn't paid for, so it automatically was unstable financially. Then there was an agreement that you couldn't negotiate with the drug companies for the cheapest available price on drugs. The American people pay about 77 percent more for drugs than any other country -- 77 percent. Almost twice as much as other countries do.

So what we've said is, as part of reform, let's negotiate with the pharmaceutical companies; we'll cover more people -- that means potentially the pharmaceuticals will have more coverage -- or more customers -- but as part of the deal, they've got to start providing much better discounts on their drugs. They've already committed that if the health care reforms pass, they would provide $80 billion worth of discounts. That would be enough to cover about half of the doughnut hole.

So, right off the bat, right now, without further negotiations, the drug companies have already committed that they would reduce -- they would cut in half the costs that folks have to go through when they're in the doughnut hole right now. That's money directly in their pocket that could be in their retirement savings.

I think we can get potentially an even better deal than that, because we're overpaying 77 percent.

But the problem is if we don't get health care reform, the pharmaceutical industry is going to fight for every dime of profits that they're currently making -- and filling that doughnut hole is going to be very expensive because when the Medicare Part D was originally passed nobody put in provisions to pay for -- and so putting even more money into it at a time when Medicare may go bankrupt -- not "go bankrupt," but go into the red 10 years from now, that's a big problem. That's part of the reason why reform is so important.

What is pharma's motive, payback for its cooperation?

The plan negotiated between the Senate Finance Committee and PhRMA, the trade association for the pharmaceutical industry is becoming increasingly troublesome as the debate over healthcare reform continues to drag on and on.

Many people worried about the new-found spirit of cooperation by the pharmaceutical industry when it was a guest/participant with others in the medical/insurance and healthcare industry at The White House.

This was after all the industry that had benefited from the last-minute engineered by then-LA Congressman Billy Tauzin that excluded negotiations for Medicare Part D prescription medicines, gave us the legacy of The Doughnut Hole, and helped pharmaceutical companies gain windfall profits.

And, it was former Congressman Tauzin who became a poster boy for pharma payback when he was rewarded with the $2 million a year job as head of PhRMA.

During the election, candidate Obama supported price negotiation for Part D medicine prices, and personal importation of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One countries. While in the Senate, he was even a co-sponsor of personal importation legislation and early in his administration provided budget support for importation.
Now, these positions seem to have been replaced with "outreach" to the drug companies, which have shown their appreciation by pledging to cooperate with health care reform, and even to reduce prescription drug prices for seniors in The Doughnut Hole by as much as $80 billion.

So sure of its position is PhRMA that during the President's meetings in Europe, with the Pope and then his African visit, that Tauzin boasted that at a meeting at The White House an unnamed aide had told him that importation might not be necessary since the industry was being so cooperative and that the other savings from the reforms might be so great as to make lower drug prices unnecessary.

In other words, even though pharma has imposed upon the American public the highest drug prices in the world, that's "OK" and it will be allowed to continue its predatory pricing rather than having to reduce prices.

It is a bold move by Tauzin to make statements about Administration policy. Our attempts to identify the source of the statement about no need for importation have elicited no reaction from The White House press office, even though we were promised two weeks ago that the inquiry had been directed to the proper people and that we would receive an answer. So much for transparency and open government.

We should have had an inkling of the possibility that an Obama administration might crumble on importation when, during the election, Dora Hughes, a medical advisor for the Obama campaign, said that the candidate, if elected, might be willing to change his position of support of importation.
At that time, we sought clarification from campaign spokespersons and were assured that candidate Obama's support of importation was as strong as ever.

Back to the present: policy-makers and many advocates continue to point to The Doughnut Hole offer by PhRMA as 'good' for seniors. But, there is confusion about details of the arrangement. And, as some have noted, by lowering prices for those in The Doughnut Hole, they will only be in many instances the same lower prices for a temporary time as the regular, everyday prices paid by citizens in other countries. Why shouldn't such prices be negotiated for all medicines.

The question must also be asked: Since there is a proven record of personal importation of safe, affordable medicines from licensed, registered pharmacies in Tier One Countries (those whose oversight and regulations of pharmaceutical medicines and pharmacies meet or even exceed those of the U.S, why shouldn't such personal importation be a part of public healthcare policy? Or has PhRMA, as indicated by Tauzin's statement after his White House meeting, negotiated restrictions on such importation, perhaps even seizures of vital medicines, which was banned by the U.S. Congress in 2006 and which has arisen more recently as Senator David Vitter (R-LA) successfully sponsored an amendment to ensure that U.S. customs is forbidden to engage in such seizures? Added to this, since the 'full price' as set by PhRMA will be credited towards satisfying The Doughnut Hole, it means that seniors who have been unable to purchase medicines while in the Hole will hopefully be able to continue their medications and will get out of The Doughnut Hole where they can has catastrophic coverage.

At that point, the medicines return to full price with the U.S. government paying 95 percent of full costs, generating a government-supported windfall for pharma. Is this what PhRMA negotiated with the U.S. Senate? And is this a part of the price we must pay for such 'cooperation?' In the next few postings, we show why this might only be the tip of the iceberg.

Time for critics of importation to look closer to home

Our most recent posting, actually a reposting, of an earlier criticism of Dr. Marv Shepherd, who, in his role as Director of the Center for Pharmacoeconomic Studies and Chairman of the Pharmacy Administration Division at the University of Texas-Austin College of Pharmacy, warned about the dangers of prescription medicines sold via internet mail-order pharmacies, suggesting that anyone making such an order, risked getting unsafe and/or counterfeit medicines, prompted a response from one reader who suggested that we lacked the courage of our convictions because while the Doctor 'signed' his papers, we published anonymously.

The writer failed to notice that sections of our blog site clearly identified us as the publisher of the site, so we expanded our identification. Interestingly, the critic had signed his/her response, 'Anonymous'.

But to move on. Let's see how concerned Dr. Shepherd and others who make misleading charges in an attempt to discourage individual importation of safe, affordable medications from licensed registered pharmacies are about the safety standards of the pharmaceutical industry itself.

This news release from the Missouri Attorney General indicates how two leading manufacturers risked the safety of Americans by their failure to report negative effects of two medicines they produced.

It is especially interesting to note that the attorneys general of 36 states were involved in the 'settlement' with Merck and Schering-Plough, but look where the drugs come from--Singapore, where the companies had a joint venture, named somewhat uncreatively MSP-Singapore.

So here is our standing invitation to Dr. Shepherd to show that he is truly concerned about prescription drug safety and holding pharma accountable for honest, open communications.

Using the University's PR budget, we urge him to do a study on bad medicines foisted upon the American public. Identify the companies, the medicines, and the potential health impact of the deception of pharma. Then, issue a news release about the need to make sure that pharma doesn't endanger the health and well-being of Americans.

The release follows. It is evident that the health threat to U.S. citizens from the misinformation of pharma is more of a threat than personal importation of safe, affordable prescriptions from licensed, registered pharmacies in Tier One countries.

Attorney General Koster announces Missouri to receive $100,000 in
settlement with Merck and Schering-Plough
--drug companies slow to disclose negative drug-study results--

Jefferson City, Mo. -- Attorney General Chris Koster today
announced a multi-state settlement with Merck & Co. Inc, Shering-Plough
Corporation, and a joint venture of the two companies, MSP Singapore
Company, LLC.

“When pharmaceutical companies slow reports of negative
drug-study results they are as good as lying to the public,” Koster
said. “It is unconscionable that a drug company would withhold
information that physicians and their patients need to make good
health-care decisions,” Koster said. “The agreement with Merck and
Schering-Plough sends a strong message that this Attorney General’s
office will be vigilant on public health issues and that we will not
allow businesses to put profits before patients.”

The settlement resolves an investigation into the companies'
lengthy delay in releasing negative results from the clinical trial
called ENHANCE (Ezetimibe and Simvastatin in Hypercholsterolemia
Enhances Atherosclerosis Regression). In this study, the
cholesterol-lowering drug Vytorin (a combination of the drug Zetia and
simvastatin) was no more effective reducing formation of plaque in
carotid arteries than the cheap, generically available
cholesterol-lowering drug simvastatin. Although ENHANCE ended May 2006,
a partial reporting of negative results did not occur until January 2008
and complete results were not published until the following April.
Prior to release of study results, Vytorin had been heavily promoted in
direct-to-consumer advertisements.

The settlement terms that now apply to Vytorin and Zetia are
requirements to:

● Obtain pre-approval from FDA for all direct-to-consumer
television advertisements;

● Comply with FDA suggestions to modify drug advertising;

● Register clinical trials and post their results;

● Prohibit ghost writing of articles;

● Reduce conflicts of interest for Data Safety Monitoring
Boards that ensure the safety of
participants in clinical trials; and,

● Comply with detailed rules prohibiting the deceptive use
of clinical trials.

In addition to these terms, the companies agreed to pay the
investigation costs of the 36 states participating in the settlement.
Missouri will receive $100,000 for its work on the investigation.

It's Deja Vu All Over Again

Earlier, we noted our concern over the apparent bail-out by The White House regarding PhRMA's Billy Tauzin, as he smugly announced that TWH suggested that personal importation of safe, affordable medicines from licensed registered pharmacies in Tier One Countries, those generally recognized as having standards of safety and efficacy that meet or exceed those of the U.S., might no longer 'be necessary' because of the 'savings' provided by comprehensive health care reform.

If we needed any proof that it was the signal for a launch by the pharmaceutical industry and its friends against moves to provide such vital medicines and provide some pricing pressure upon the predatory tactics of pharma, it has been provided by an 'old reliable', Dr. Marv Shepherd, who has devoted years of campaigning against importation of vital medicines.

We first came across Dr. Shepherd some years ago when we were still so naive as to believe that we could reach out to correct the misstatements made by some against importation. We were told by the Doctor at that time that the comments (about Terrorist links to Canadian pharmacies) he had made were merely raised at a meeting he was attending, and he further implied that he had a limited exposure to the issue.

When we found out the true extent of his involvement in the 'issue', we had an attack of righteous indignation, and published the following blog on another site. Now, just today, Dr. Shepherd has resurfaced to attempt to scare to death (likely by not taking vital medicines they cannot otherwise afford) of those Americans seeking the health benefits of safe, affordable prescription medicines. As a public service, we reprint the earlier article. As you read the list of speaking engagements and topics, remember, this was by a man who purported to me that he had little involvement with the subject of importation...the article follows. We make no claims about any funding that might or might not have been provided, although the latest release comes from the University:

The Past Leaves a Trail
Yesterday, we posted our news release link and blog on the activities of Dr. Marv Shepherd, who heads up something called the Pharmacoeconomic Studies Center at the University of Texas, laying out his record of misdirection with his article claiming that prescription drugs from Canada were 'counterfeit' and helped fund terrorist activities.

That he also took the time to rap the Vitter-Nelson amendment, approved 68-32 by the U.S. Senate, forbidding the seizure of prescriptions from licensed, registered pharmacies, indicated to us that he was really just carrying water for the pharmaceutical companies.

We had given him a chance to clarify his position. He claimed in a telephone call that he had heard something about the issue (terrorist links) at a California meeting earlier this summer. A little more research shows just how deep his lack of credibility goes and further validates that he has for years been mouthing the position of the large drug companies.

Here, from his web site, is a listing of papers, interviews and presentations he has made on pharmcoeconomic studies, whatever in the blazes that it. To me it looks more like a long history of opposition to access to safe, affordable prescriptions from outside the U.S., even if they are form licensed, registered pharmacies subject to the oversight of their own country's regulatory bodies. Perhaps Shepherd should be talking more about the recent finding that the FDA directory of prescription medicines is severely outdated.

Notice the phrases in the titles...'threats', 'dangers', 'vulnerbility', 'safety concerns', 'myths', 'effects on quality of care', just to name a few. Also, in his presentation on the impact of the millions of dollars spent on advertising directly to consumers, his conclusion was "Even though every year the javascript:void(0)industry spends millions of dollars on DTCA of prescription dmgs we cannot conclude that it influences drug prices." It is obvious that Shepherd's latest parroting of drug company claims was just another in a long series of papers, studies, etc. that lack any true academic standing. It's a shame that the people of Texas allow such a proud university to be used by large drug companies.

If you need more proof, here's the list of presentations by Dr. Shepherd...you are free to draw your own conclusions...why was he talking about the myths of reimportation to the Deparatment of Defense, for example...but one that is evident is that Shepherd was less that forthright with me when he tried to explain away his interest in counterfeiting as something that he had just heard about and felt compelled to write on, but was actually continuing a role of many years:

Presentations by Dr. Marv Shepherd
1."Prescription Drug Importation" presented at the 2004 Health Care Conference, Texas Association of Business and Texas Business Group on Health, Dallas, TX, September 8, 2004.
2. "Counterfeit Medicines: The American Experience" presented at the World Congress of Pharmacy and Pharmaceutical Sciences 2004, 64 th Congress of the Federation of International Pharmacists, New Orleans, LA September 9, 2004
3. "Threat of Drug Importation" presented at the West Texas Pharmacists Association, Lubbock, TX, September 18, 2004.
4. "Issues in Drug Importation" presented at the Illinois Pharmacists Association Annual Meeting, Arlington Heights, IL September 19, 2004.
5. "Threat of Drug Importation" presented at the Western New York Society of Health System Pharmacists meeting, Buffalo, NY, September 16, 2004.
6."Hazards of Drug Importation" presented at the University of Texas College of Pharmacy, Legends of Pharmacy Open and Learning on the Links Continuing Education Program, Austin, TX, September 24, 2004
7. "Threats of Drug Importation and Vulnerability of Our Drug Distribution System," presented at Florida A&M University Forum Series, College of Pharmacy and Pharmaceutical Sciences, Tallahassee, FL, October 5, 2004.
8. "Threat of Drug Importation," presented at the ARMSRx Ease of In-Sourcing Conference, Tortola, Bristish Virgin Islands, October 10, 2004.
9."Integrity of the Drug Supply System: Threats of Counterfeit Pharmaceuticals" presented at the Academy of Managed Care 2004 Educational conference, Baltimore, MD, Oct 15, 2004
10. "Drug Importation and the Vulnerability of Our Drug Supply Chain," presented at the American Society of Health-System Pharmacists 2004 Management Conference for Leaders in Pharmacy, Chicago, IL, October18, 2004.
11."The Importation of Drugs," presented at the Annual Meeting of the American College of Clinical Pharmacists, Dallas, TX, October 26, 2004.
12. "Wakeup Call: A Perfect Storm is Brewing" presented at the District VII and VII NABP-AACP Annual Meeting, Las Vegas, NV, October 28, 2004.
13. "Threat of Drug Importation and the Vulnerability of Our Drug Distribution System," presented at the Federal Pharmacy Conference, University of Texas, College of Pharmacy, Austin, TX, November 5, 2004
14."Statement on Prescription Drug Importation," presented and submitted to the Texas Legislative Conservative Coalition Research Institute Conference, Austin, TX, November 9, 2004.
15."Safety Concerns regarding Imported Medications," presented at the Understanding Importation Impact on Health Care Outcomes Conference, Madison, WI, November 11, 2004.
16. "New Drugs in the Pipeline and New Generic Releases," presented at the Department of Defense Pharmacoeconomics and Pharmacy Benefit Conference, San Antonio, TX, January 11, 2005
17. "Myths of Drug Importation" presented at the Department of Defense, Pharmacoeconomics and Pharmacy Benefit Conference, San Antonio, TX, January 12, 2005
18. "Effects of Drug Importation on Quality of Care," presented at the Coalition of Rheumatologists Advocacy Conference: Impact of Pharmacy Programs on Access to Rheumatologic Care, San Francisco, CA, January 22, 2005.
19."Myths of Drug Importation," presented at the Federation of American Hospitals Conference, Washington, D.C., February 28, 2005.
20."Drug Industry: Importation and Reimportation of Drugs," presented at the College of Psychiatric and Neurologic Pharmacists Annual Conference, San Diego, CA, March 12, 2005.
21. "Myths of Drug Importation," presented at the Michigan Health and Safety Coalition Patient Safety Conference, Dearborn, MI, April 8, 2005.
22."Global Pharmaceutical Marketplace/Importation," presented at the Food Marketing Institute 18 th Annual Supermarket Pharmacy Conference, New Orleans, LA, April 12, 2005.
23."Patients at Risk: Illegal Importation and Counterfeiting of Drugs," presented the Texas Organization of Rural and Community Hospitals Conference, Dallas, TX, April14, 2005.
24."Update on the Medicare Part D Prescription Drug Program," present at the College of Pharmacy University of Texas, Advisory Council, April 15, 2005.
25."Safety of America's Drug Supply Chain," presented at the Illinois Council of Health System Pharmacists and the Missouri Society of Health-System Pharmacists Spring Meeting, St. Charles, MO, April 16, 2005.
26."Internet Drug Traffic and Diversion of Prescription Drugs," presented at the Train the Trainer Drug Conference, Drug Enforcement Administration, El Paso, TX, April 20, 2005
27. "Myths of Drug Importation," presented at the Drug Enforcement Administration (DEA) Train the Trainer Conference, El Paso, TX, April 20, 2005.
28."The Truth and Consequences of Drug Importation," presented at the New Jersey Society of Health-System Pharmacists Annual Meeting, New Brunswick, NJ, April 21, 2005.
29."Myths of Drug Importation," presented at Argus Health Systems, Kansas City, MO, April 28, 2005.
30. "Policy Implications: Drug Quality, Safety Issues and Threats from Imported Medications," presented at the International Drug Importation Conference, Institute of Health Law Studies, California Western School of Law, San Diego, CA, June 3, 2005.
31."Myths of Drug Importation," presented at the Rochester NY Physicians Meeting, Rochester NY, June 13, 2005.
32."Myths of Drug Importation," presented at the Pfizer Pharmaceutical Speaker Program, Williamsville, NY, June 14, 2005.
33."Drug Importation: Global and Mexico," presented at the Healthcare Distribution Management Association 2005 Distribution Management Conference & Expo, Orlando, FL, June 16, 2005.
34."Threats of Drug Importation and the Vulnerability of Our Drug Distribution System," presented at the Arizona Pharmacy Alliance Annual Meeting, Phoenix, AZ, June 18, 2005.
35. "Drug Importation and the Vulnerability of Drug Distribution System," presented at the PharmaCare 3 rd Party Administrators Annual Conference, New Port RI, July 11, 2005.
36. "Counterfeit Drugs and the Vulnerability of Our Drug Distribution System," presented at the Texas Academy of Family Physicians Annual Meeting, San Antonio, TX, August 15, 2005.
37. "Thoughts on the Future of Pharmacy," presented at the Annul Pharmacy Conference of the Texas Community Health Centers, Austin, TX, August 25, 2005.
Research Presentations
38. Dastani H and Shepherd MD, "Predictors of Compliance and Persistence to Statin Therapy Among Texas Medicaid Patients," poster presentation at the annual meeting of the International Society of Pharmacoeconomics and Outcomes Research, Washington DC, May 16, 2005.
39. Nair R, Shepherd MD, Barner J, Lawson K, Wilson J and Warner D, Evaluation of Factors Related to Diagnosis of Hyperlipidemia: The Roll of Direct-to-Consumer Advertising Expenditures, Health Insurance Coverage and Gender, poster presentation at the annual meeting of the International Society of Pharmacoeconomics and Outcomes Research, Washington DC, May 16, 2005.
40. Shah S, Novak S and Shepherd MD, Evaluation and Comparison of Different Models of Metabolic Syndrome Using Confirmatory Factor Analysis, poster presentation at the annual meeting of the International Society of Pharmacoeconomics and Outcomes Research, Washington DC, May 17, 2005.
41. Panjabi, SS and Shepherd MD, Confirmatory Factor Analysis of the Beck Depression Inventory, poster presentation at the annual meeting of the International Society of Pharmacoeconomics and Outcomes Research, Washington DC, May 17, 2005.
42. Dastani H Shepherd MD, and Sasane R, Compliance and Persistence to Statin Therapy Among Texas Medicaid Patients, presented at the annual meeting of the Academy of Managed Care Pharmacy, Denver, CO, April 22, 2005.
Publications:
43. Shepherd, MD, "Counterfeit Drugs and the Pharmacist's Responsibilities" CESolutions, ( http://www.cesolution.com/) 1-12.
44. Shepherd, MD, "Drug Quality: Safety Issues and Threats of Drug Importation," California Western Law Review/International Law Journal , Special Edition, Summer 2005. 77-88.
45. "Alternatives in Savings in Purchasing of Medications," The Senior News Source , Vol 7, Issue 2, April 15, 2005. p.1
"Examination of the Relationship of Direct-to-Consumer Advertising Expenditures and Drug Price," Drug Information Journal , Vol 39, No.1, 2005, 13-24.
ED-OP Articles
46. Shepherd MD, "U.S. Should Solve Its Own Problems" Vancouver Sun , November 2, 2004, A13.
Shepherd, MD, "Canada is Not the Answer" Chicago Sun Times , October 23, 2004
47. "What if Canada Says 'No' to US on Drug Importation" USA TODAY , December 29, 2004, A13.
Interviews
48. Bioworld Today, "Canada Considers Stopping U.S. from Importing Drugs," January 18, 2005
49. KTBB-AM - Tyler TX - Talk Radio Interview, Roger Gray Show, January 11, 2005
50. KCRS-Midland/Odessa -Talk Radio, Robert Hallmark Show, January 11, 2005
DFW Metro Networks -Dallas TX, Amber Browne, January 20, 2005
Cooking Lite Magazine
51.San Antonio Express News , Editorial Advisory Board, January 11, 2005.
52.Austin American Statesman , Editorial Advisory Board, January 18, 2005
53.Houston Chronicle , Editorial Advisory Board, February 2, 2005
54. News Press Conference at the Texas Capital on Drug Importation, April 6, 2005

Would anyone like to make book on what he talked about at the Editorial Advisory Boards and the talk shows? I wish I had his frequent flyer miles since he has been all over the country...almost always protecting the position of large pharmaceutical companies. What in the world did he have to say to Pfizer, though?

Seniors Website Publisher expresses 'dismay' at purported White House stance on medicine reimportation

Publisher of leading information website for America's seniors,caregivers, advocates, policy-makers says purported White House stance on prescription medicine importation needs to be rebuked

Jul 08, 2009 – St. Louis, MO—The publisher of www.TodaysSeniorsNetwork.com, a leading informational website on aging issues for America’s seniors, caregivers, advocates and policy-makers, has expressed his ‘dismay’ at the announcement by a pharmaceutical industry representative that the Obama Administration has said that access to safe, affordable medications from licensed, registered pharmacies in Tier One countries might not be necessary to reduce the cost of prescription medicines for Americans.

Daniel Hines
, publisher of www.TodaysSeniorsNetwork.com, was responding to a statement by Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America (PhRMA) after an industry meeting with White House Staff, Tauzin is a former Louisiana Congressman, most noted as the Congressman who made possible provisions in Medicare Part D that ensured windfall profits and locked-in markets for the pharmaceutical industry, free of price negotiation, and establishing the ‘Doughnut Hole’. Upon resigning from Congress, Tauzin was named to his current PhRMA position at a $2 million annual salary.

“Tauzin implies that the White House believes that claimed savings of $80 billion over 10 years ‘negotiated’ with the Senate Finance Committee to reduce the costs of drugs sold to seniors in the Doughnut Hole, and other hoped for savings from comprehensive healthcare reform will be so great as to make individual importation ‘unnecessary’ “ Hines observes. “This is a fantasy that the American public should reject.”

Hines notes that the claimed Part D savings come on the heels of windfall profits made possible by price increases by the pharmaceutical industry over the life of Part D that have been so great as to force untold numbers of America’s elderly to either split their medications, or even quit taking vital medicines.

“:Also, the Congressional Budget Office is expected to score the drug companies’ ‘deal’ as saving far less than the claimed $80 billion,” Hines notes. “And, one must question, what is the leverage of the pharmaceutical industry to ‘negotiate’ legislation from the U.S. Congress, elected by the American citizenry.”

He urged President Obama to reaffirm his stance during the election campaign of support for the inclusion of individual purchases of safe, affordable prescription medicines from Tier One countries (those that are recognized as having standards of safety and oversight of licensed, registered pharmacies in their countries that meet or exceed those of the U.S. FDA).

“This could greatly reduce individual costs, while, at the same time, keeping the pharmaceutical industry ‘in-line’ rather than giving it a free-hand to raise prices and control supplies as it wishes,” Hines says. “By directing the Secretary of Health and Human Services to enter into some form of reciprocal arrangements, it would be possible to designate Tier One countries and to identify licensed pharmacies in those countries from which U.S. citizens may purchase their medicines, all the while confident of the safety and efficacy of the medicines, as well as the standards of the pharmacy filling the prescriptions.

“At the same time, the Administration should take two steps to further lower prescription prices: (1) Allow the inclusion of lower-cost personally imported prescription medicines into Part D plans to further lower costs to plan enrollees, generating savings for the government, and (2) keep its election campaign pledge to negotiate with the pharmaceutical industry, rather than accepting a deal by the industry to lower prices on the conditions of enactment of provisions within any legislation that will actually further increase and guarantee their markets at the expense of the American public.”

Importation bill has chance to offer example of concern for ALL U.S. citizens, leadership, innovation

The news hit with the suddenness of a surprise attack early Saturday, June 20—the Pharmaceutical industry had made a late night call to Senator Max Baucus (D-MT) to tell him that is was willing to cooperate by pledging $80 billion over the next decade in resolving one of the biggest problems (and resulting criticisms) of Medicare Part D, The Infamous Doughnut Hole.

The facts surfaced by Monday afternoon however, as it became evident that pharma’s move really was nothing more than a carefully crafted and possibly successful attempt to circumvent several challenges facing it—the possibility of price negotiation for Part D medicines, and the potential contribution that could be provided by allowing personal importation of safe, affordable medicines from licensed, registered pharmacies in Tier One designated countries.
The Doughnut Hole should have been called ‘The Black Hole.’ Seniors were forced to continue paying their premiums, but their coverage was ‘suspended’ when drug costs reached $2250. They had entered The Doughnut Hole, where they would pay 100 percent of their prescriptions for the next $3600—even though they still had to pay for their premiums (a windfall for insurance companies). After paying the $3600, the ‘catastrophic’ level was reached, and the seniors who had survived The Doughnut Hole, were eligible for renewed coverage with low cost co-pays.

The fiscal and medical hit upon the elderly was immediate. Many seniors simply quit taking their medicines or began ‘splitting’ pills. Either action not only derailed the claimed hoped-for goals of Medicare Part D, it caused untold numbers of elderly to gamble their health, well-being and perhaps even their lives by the self-denial of vital medicines that had been forced on them by a pharmaceutical-influenced Congress that enacted Part D. Billy Tauzin, the former Congressman from New Orleans who was instrumental for many of the 11th hour (and 59 minute) changes that shaped Part D was rewarded with a multi-million-dollar position by PhRMA, the influential and well-heeled trade group for the drug companies.

A proposed solution to relieving the burden of The Doughnut Hole dilemma—price negotiation for drugs-- soon became a favorite of politicians, and repeated calls were made from untold numbers of stumps, town hall meetings, and locales where the pols could promise the elderly that help was on the way.

With the election of President Barack Obama, a Democratic House and a Democratic Senate, negotiation seemed ready to be moved from stump speeches to reality.

But, it is said that politics makes strange bedfellows. And, the push for healthcare reform soon created a lot of odd sleeping arrangements. Many of us winced when PhRMA joined with FamiliesUSA, a leading progressive, hard-working and well-respected advocacy group, to work for ‘healthcare reform.’ What, we asked, was the industry looking for? Images of the Fox in the Henhouse, the camel with his nose under the tent, flashed though our minds.

Added to this was the White House meeting President Obama arranged with industry groups representing insurance companies, PhRMA, hospitals, and other healthcare industry groups. Our concerns were quickly validated when a White House statement about pledges to cut the growth of health care costs was actually nothing more than a pledge to reduce the rate of growth by not increasing prices as much as before. The President needs to remember what John Kennedy said about big business special interest groups and what a bunch of SOBs they were.

The fact is that the ‘pledge’ was actually not a true savings. It would be a bit like buying your groceries at a store that has raised its prices 20 percent for the past few years. But, to ‘save money’, it says it will raise its prices only 10 percent next year, so instead of groceries that cost $100 per week in year one, the next year they would cost $110 instead of $120. The store owner could then tell consumers that each had saved $10 in year two, even though they were paying more for the same groceries. Only the rate of the increase was less than in previous years.

This type of math should have been the tip-off that the pharma ‘commitment’ to aiding seniors in The Doughnut Hole isn’t what it at first seemed to be.

On Sunday, President Obama issued the following statement about the agreement with the drug companies:

"I am pleased to announce that an agreement has been reached between Senator Max Baucus and the nation’s pharmaceutical companies that will bring down health care costs and reduce the price of prescription drugs for millions of America’s seniors. As part of the health reform legislation that I expect Congress to enact this year, pharmaceutical companies will extend discounts on prescription drugs to millions of seniors who currently are subjected to crushing out-of-pocket expenses when the yearly amounts they pay for medication fall within the doughnut hole any payments by seniors not covered by Medicare that fall between $2700 and $6153.75 per year. The existence of this gap in coverage has been a continuing injustice that has placed a great burden on many seniors. This deal will provide significant relief from that burden for millions of American seniors.

"The agreement by pharmaceutical companies to contribute to the health reform effort comes on the heels of the landmark pledge many health industry leaders made to me last month, when they offered to do their part to reduce health spending $2 trillion over the next decade. We are at a turning point in America’s journey toward health care reform. Key sectors of the health care industry acknowledge what American families and businesses already know - that the status quo is no longer sustainable. The agreement reached today to lower prescription drug costs for seniors will be an important part of the legislation I expect to sign into law in October. I want to commend House chairmen Henry Waxman, George Miller and Charles Rangel for addressing this issue in the health reform legislation they unveiled this week. This is a tangible example of the type of reform that will lower costs while assuring quality health care for every American."
It was to be Monday before the facts began to surface. Simply put, PhRMA had negotiated an arrangement that would become law only if Congress enacted comprehensive healthcare reform, a part of which would include expanded coverage for more Americans, creating new, additional and profitable markets for the pharmaceutical industry. It is distressing to once again witness the ability of pharma to define issues to its advantage. Perhaps I need a refresher course in civics, but why does the industry have to ‘agree’ to cuts that are intended to be a part of the governing legislation enacted by the U.S. Congress? What option do they have?

Also, why is the Obama Administration so ready to heap praises upon the drug companies, all of which have reaped whirlwind, virtually ensured profits at the expense of the American public that has been denied access to the health benefits provided by access to vital medicines because it must pay the highest cost in the world for its prescription medicines?

But, it is an ill-wind that blows no good. Last Fall, before the elections, a group of advocates for senior advocacy groups from areas across the country, met in Washington, DC to shape support for personal importation of prescription medicines from Tier One countries. At that time, the participants reached a consensus that the importation concept should be included as a part of discussion about comprehensive healthcare reform, a ‘third-leg’ of the stool, because such access to vital medicines is essential to the health and well-being of Americans. It also urged consideration of the beneficial budgetary impact that could be provided though the inclusion of personal importation of prescription medicines into Part D thereby remedying plan shortcomings while saving money for the elderly, protecting their health and creating real savings for the Plan.

Sources tell us that moves have made recently by supporters of importation to define a stronger argument for importation of prescription medicines within the framework of the healthcare debate. We applaud such action. Now, there is an additional opportunity to address the benefits of improved health and savings by fine-tuning the healthcare debate to explore other opportunities for personal importation and defining a role for personal importation in Medicare Part D. Senators Dorgan and Snowe, the two legislators most identified with importation, have issued a statement that reflects their realization that the pharma 'offer' really does not address the challenge of lowering prescription drug prices. And, already, there is a growing realization that the pharmaceutical industry's motives are self-serving.

It is time to call out the pharmaceutical industry. There are legitimate questions that deserve answers about the motives of pharma. It has reaped the benefits of guaranteed pricing for Part D that has led to windfall profits. The claimed or hoped-for savings,while beneficial to individuals, is too little-too late for many elderly. As to the claimed savings to be scored by the Congressional Budget Office, there is a growing realization that possible trade-offs to gain pharma support might actually lead to increased--and virtually guaranteed--sales and earnings.

There is a role for personal importation in helping provide a solution to providing safe, affordable prescription medicines for all Americans. We believe the pharma moves should lead to increased discussion of creating such access, free of what we believe to be unnecessary delays by empowering Secretary Sebelius to designate Tier One countries whose standards of oversight, safety, and efficacy meet of exceed those of the U.S.

Dorgan-Snowe needs changes (Chapter 2)

Summary: Earlier, Daniel Hines, publisher of www.TodaysSeniorsNetwork.com and a long-time and continuing supporter of personal importation of safe, affordable prescription medicines from pharmacies in Tier One countries, expresses concerns about current limitations on personal importation in U.S. Senate Bill 525, popularly referred to as Dorgan-Snowe, and urged supporters and sponsors to consider ramifications of the proposed legislation upon access to prescription medicines via the Internet or mail-order—access, which ironically might actually be decreased because of changes in the operations of those pharmacies created by the legislation, sources of supply, and a need to adapt the legislation to the challenges and opportunities that personal importation can provide.In this post, he deals with specific issues:

(1) Importation of medicines is an established fact. The right of individuals to make purchases via importation is established by the fact that a medicine that is unaffordable is unavailable, and Americans therefore have the right to make such purchases. The support on behalf of such access was the result of a classic populist movement by Americans, primarily the elderly, against the predatory pricing practices of pharmaceutical companies.

(2) The bill as presented fails to address the important role of access to prescription medicines as a part of the tremendous opportunity to be a part of comprehensive healthcare reform, and is instead a ‘stand-alone’ bill. This is evidenced by the fact that while drafts of healthcare reform bills such as that of Senator Ted Kennedy (D-MA) have a brief mention of access to prescription medicines as a part of vital healthcare for all Americans, no mention is made of the potential contribution and benefit that could be made by expanded access to safe, affordable prescription medicines from licensed, registered pharmacies in Tier One countries. The supporters of importation on The Hill have missed a tremendous opportunity to establish a presence for importation of medicines to be integrated into the discussion over opportunities for importation of prescription medicines as a part of comprehensive healthcare reform.

(3) One of the biggest challenges facing elderly Americans is the tremendous price increases of prescription medicines in Part D and the larger ‘Doughnut Hole’ in which seniors in the plan are forced to pay out-of-pocket for their prescriptions, while still paying a premium for coverage they are not receiving until their out-of-pocket expenditures reach the catastrophic level. Many never do. That is why we supported the bill introduced in the last Congress by Representative Dennis Kucinich (D-OH) to include imported medicines into the choices for Part D recipients, and why many advocates of importation believe that, properly constructed, there is an opportunity for importation to not only serve the health needs of Americans, but to contribute to budget savings. Yet, there is no provision at this stage of the healthcare reform debate that is just evolving about such a role for importation as an element of Part D, another opportunity lost.

(4) The legislation does not address issues of sourcing of medicines from Canadian pharmacies that reflect changes over the years in Canadian pharmacy operating models. Instead, there is a trapdoor that will stop Dorgan-Snowe from reaching its hoped-for goals because in its first year it limits personal importation of medicines to those from Canadian pharmacies with the medicines coming from Canada only. This in spite of the fact that there are estimates that as much as 80 percent of the prescriptions being fulfilled by Canadian pharmacies comes from Tier One countries whose standards meet or exceed those of the U.S.. But these will not be allowed to be imported into the U.S. by Canadian pharmacies, even though large numbers of Americans are currently doing so, enjoying the health benefits of access to vital medicines that are safe and affordable.

(5) The safety of medicines from pharmacies in Tier One countries such as Australia, New Zealand, the European Community and Japan is an established fact. Ironically, they will be designated for purchase by U.S. consumers after the first year of the limitation in (2), but only from U.S. pharmacies or wholesalers. Why is there a year-wait for such access, particularly in light of the probable shortage of medicines available from Canadian pharmacies because they will be unable to fulfill orders by utilizing sourcing from those same countries?

(6) How eager are Canadian pharmacies to be the engine that drives Dorgan-Snowe? Projections of anticipated revenues by policy-makers fail to account for the possible loss of sales by Canadian pharmacies that will lose access to medicines from Tier One countries as noted above. More significantly, the tremendous drop in the number of mail-order or Internet pharmacies in Canada will have an impact on the funding of importation. The Canadian International Pharmacy Association reportedly has 21 members, a far cry from the 140 pharmacies cited by Senator Charles Grassley (R-IA) that he counts on to generate the sales and the revenues that will contribute to the implementation and administration of Dorgan-Snowe. Over the years, there has been a concern expressed by Canadian pharmacies and Canadian policy-makers over ‘bulk shipments’ to the U.S. Many Canadian authorities fear a scenario in which Canada becomes ‘America’s Drug Store.’ Although when wholesale shipments are authorized in a year there will be the opportunity for shipments to pharmacies and wholesalers in this country from sources other than Canada, what might be the impact if Canadian officials fear a loss of access to medicines for their own citizens? Perception molds reality. Also, how may Canadian pharmacies will choose to participate in Dorgan-Snowe, with its registration fees, posting a $1 million bond, and seeing their margins reduced by other fees based on sales? If they choose not to participate, but continue sales to U.S. citizens, how will the provisions of the bill be enforced? Will they be declared ‘bogus’ pharmacies even though they are operating under the jurisdiction of their particular Provinces? The risk is that untold numbers of Americans might be denied vital medicines, with possible severe health consequences.

(7) How will Americans replace the medicines from other Tier One countries such as Australia, New Zealand, Great Britain, Japan and the European Community that they are now receiving through individual purchases from legitimate, authorized pharmacies that are already complying with standards in their countries that meet or exceed those of the U.S.? These are medicines that are now available but which might be denied for twelve months. Why should there be a year-long wait to establish the arrangements for wholesalers and pharmacies that might want to establish U.S.-based operations to import medicines or to administer plans to provide huge numbers of U.S. citizens the health benefit of access to safe, affordable medicines, access which would otherwise might be denied. Why, when the safety and efficacy of these medicines is already proven, and will be accepted in a year by the U.S., should Americans be denied the ability to make such purchases individually at this or any other time?

(8) The safety of imported medicines from legitimate pharmacies is a fact of life. There are, as far as I have been able to ascertain, no recorded deaths from medicines imported by individuals from legitimate, authorized pharmacies outside the U.S. Sadly, the same cannot be said of medicines from U.S. pharmacies. As a writer for The American Enterprise Institute, hardly a friend of importation, noted: “Only the stupid, lazy or woefully uninformed," would purchase medicine from a bogus pharmacy,” citing the many reliable sources to utilize to verify the safety of pharmacies. As noted, it is a fact that legitimate, authorized pharmacies in a Tier One country of origin must meet standards that meet or exceed those of the U.S. And, all anyone has to do to verify a Canadian pharmacy is to visit the web site of The Canadian International Pharmacy Association. The tragedy of persons buying from counterfeit pharmacies is undeniable. But, no legitimate pharmacy will make a shipment without a physician’s prescription, nor will it ship a controlled substance. Ironically, Google alerts for prescription medicine prices, which once were reliable sources of news about pharmaceutical industry and medicines events and trends, now include numerous mention to ‘pharmacies’ selling a number of drugs—usually Viagra and related medicines—with no prescription required, a sure tip-off to an illicit pharmacy and proof that no amount of regulation can completely stop someone from purchasing from such operations. Common sense and individual responsibility have a role to play. Rather than limiting access to legitimate pharmacies, Dorgan-Snowe should expand it.

(9) The bill lacks the transparency that more citizen involvement could provide. The claim is made on the one hand that the reason for not having hearings on the bill’s proposed language is that it is virtually the same bill that has been offered in the past so there is no need for Congressional hearings. Even granting the validity of this, the fact remains that the circumstances surrounding the bill have changed. Dorgan-Snowe is a bill that, when the importation issue first arose, had defining purposes—safety, efficacy of drugs, improved public health and lower costs for medicines It was a recognition by the supporters of importation that there were benefits to be obtained from allowing Americans access to safe, affordable prescription medicines from other countries, but that there was also a need to reassure patients and families that the proper oversight would be provided to help them identify pharmacies offering those medicines. What have changed are the forces of importation, forces that will shape and determine the success of providing safe, affordable medicines to Americans , not merely measured by passage of the bill.

These forces are described above. But, for importation of medicines to achieve its hoped-for benefits of improved health and well-being of Americans through access to a regimen of vital medicines, some ‘old ground’ will have to be gone over again. We encourage the policy-makers inside the Beltway to welcome the opportunity for additional input and fine-tuning of Dorgan-Snowe that will ensure the success of the legislation for which they have worked so hard for so long. Without such consideration, the consequences might be that the legislation might actually have an impact completely opposite of what is hoped for and cause a reduction in the ability of Americans to benefit from access to safe, affordable imported medicines.