Stop Pharma from denying access for Americans to safe, affordable prescriptions

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries.

· Personal Importation of safe, affordable prescription medicines from countries outside the U.S was spurred more than a decade ago as a reaction to the fact that the U.S. has the highest prescription drug prices in the world.

· Personal importation of prescription medicines is the only option available to provide lower-cost brand name medicines for Americans.

· These medicines—from licensed, registered pharmacies in Canada and other countries with standards of oversight that meet or exceed those of the U.S.—have provided health benefits and financial relief to hundreds of thousands of Americans.

· The U.S. Congress has through repeated votes in the House and Senate expressed its support of the concept of making personally imported medicines available to U.S. citizens from pharmacies in Canada and 22 other countries whose standards of oversight for safety and efficacy equal or exceed those of the U.S.

· While a rash of bogus pharmacies and counterfeit medicines has arisen on the Internet, legitimate on-line pharmacies have taken extraordinary steps to distinguish them from bogus pharmacies.

· The pharmaceutical industry and its trade group (PhRMA) have targeted the right of personal importation of prescription medicines, which , ironically, they themselves have manufactured.

· The latest attempt to curtail access to personal importation is to define any online pharmacy from outside the U.S. as ‘bogus’ , even if an online pharmacy has met the standards of safety and efficacy of its practice required by the appropriate regulatory agency of its government.

· Opponents of personal importation have taken steps that indicate they hope to use the anti-counterfeiting intent of S 3804 as a rationale to claim that even licensed, registered pharmacies would be guilty of infringement of Copyright and Intellectual property rights.

· This would make the pharmacy liable to enforcement provisions of S 3804 which include, but are not limited to, the shutting down of domains and websites not only of the pharmacy, but could be extended to the sites of advocacy groups and individuals that support personal importation.

· Because of that, specific legislative language should be included in S 3804 to ensure that the legislation meets its intended purpose, and cannot be co-opted by special interest groups that would utilize the bill to meet their own narrow interests.

· Without the inclusion of language to more carefully define the intent of S 3804, the stage would be set for the pharmaceutical industry to take actions to restrict the right of Americans to enjoy the health benefits provided by safe, vital medicines that they otherwise could not afford.

· We believe that Americans have the right to make personal healthcare decisions including the right to purchase safe, affordable medicines from licensed, registered pharmacies, and that they have the capability to make such informed decisions in a responsible manner, free of governmental interference, and that current efforts to define legitimate pharmacies as bogus is an attempt by the pharmaceutical industry to extend its influence to impose its predatory pricing practices upon American citizens with regard only for industry profits, not the health and well-being of American citizens.

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries. We will be posting email addresses for the new session of Congress in early January 2011.

American Public has common sense answer to lowering drug prices…just do it!

The failed vote in the U.S. Senate on the Dorgan Amendment to ‘allow’ lower-cost prescription medicines from licensed, registered pharmacies located in countries that have standards of oversight that meet or exceed those of the U.S. was both tragic and unnecessary.

It was tragic to watch the tremendous courage of Senator Byron Dorgan (D-ND), a man whom I greatly admire, who has been a champion of lowering prescription drug prices through ‘reimportation’ for nearly a decade, as he pleaded, cajoled and passionately made the point that the amendment was truly the only one that would have the effect of providing savings.

It was equally tragic to see him victimized by the deal-making of the Obama Administration with PhRMA. The snake that the President has decided to pick up may still bite him, as we warned in a previous entry.

At the same time, the spectacle was unnecessary. There are several reasons:
• As we have noted before, and even though we strongly support the right of personal importation, the bill, popularly called Dorgan-Snowe, was unworkable. It relied upon assumptions that simply were not possible to achieve:
• The first-year limitation upon medicines coming only from Canadian mail-order pharmacies was naive.
• There simply are not enough mail-order pharmacies left in Canada to provide the hoped-for funding;
• By restricting the ability to purchase medicines immediately from Australia, New Zealand and Great Britain for one year, and then limiting even those purchases to U.S.-based wholesalers and pharmacies, the bill’s supporters failed to acknowledge that as much as 80 percent of the sourcing for the Canadian mail-order pharmacies comes from Australia, New Zealand, and Great Britain.
• This was not the case when ‘reimportation’ first became an issue, but while the situation has changed, the language of the amendment reflected a situation that simply no longer exists, that of several years ago. It appears that the hoped-for impact was that since President Obama had co-sponsored a bill with virtually the same language two years ago, as had his Chief of Staff Rahm Emanuel on the House side, that they would be so flattered as to support the reincarnation of ‘their’ bill, a surprising bit of naivete.
• There was no opportunity for public input into the formation of the language. Supporters were given a ‘love it or Lump it’ choice. Some accepted this direction. I never did, not because I did not support the concept of importation, but because after years of hard work and support for personal importation, my responsibility remains the health benefits and savings that personal importation generates for seniors, workers, and others, not the mere passage of a bill.
• Many of the supporters of importation failed to ask themselves a very basic question: Why should Canada, which is a sovereign nation, and which through Health Canada has standards of oversight that meet or exceed those of the U.S. FDA, allow its pharmacies, operating completely within the laws of Canada and the provinces to be subject to U.S. inspections. Rather, why was there not a move made for reciprocal agreements?

But, in addition to being unworkable, there is another reason the amendment as written and the punishment heaped upon importation supporters was unnecessary: Importation of safe,affordable medicines is well-established through the common sense of the American public.

As the pharmaceutical industry continues to raise its prices, making deals with the Obama Administration that will lead to even greater costs for Medicare Part D payments by the government, growing numbers of Americans will be able to make wise, independent evaluations of safety and efficacy, as well as costs of medicines from safe, easily identifiable sources, not only from Canadian pharmacies, but through other pharmacies in Tier One Countries.

This is yet another example that all wisdom does not generate from within The Beltway but lies with the common sense of the American people.

For years, we have contended that individual, personal importation is allowed because the FDA itself has stated that a medicine that is not available in this country may be ordered in 90-day supplies for personal use, and any medicine that is not affordable is equally unavailable.

Also, that same common sense, enables Americans to evaluate the sources of their medicines for safety and efficacy as well as price. Those who believe that the FDA is the sole source of drug or product safety need to only look at the sorry record of the agency on a number of fronts ranging from Peanuts to Heparin.

As one who supported President Obama during his Presidential quest, I must admit to a deep sense of chagrin on a number of fronts. The deals with PhRMA are just the latest in a series of failed pledges for transparency and openness in government.

If Senator Dorgan wants to proceed with his quest, I encouraged him take actions that reflect the realities of the moment, rather than a bill with language that, while deserving support in a different time, is no longer relevant…irrespective, we shall increase our efforts to help the American people have the information to make informed, wise decisions, step forward, and exercise their common sense with the selection of safe, affordable medicines from pharmacies in other countries that meet or exceed the standards of those in the U.S.

Perhaps the President can then redeem himself by directing HHS to take steps to lead to reciprocal agreements with those countries for the benefit of the health care needs of untold numbers of people in this country. But, it is not necessary to wait for him or others within The Beltway to take action.

The American people have already spoken and as they are faced with the tremendous price increases initiated by pharma, we urge advocates of lower drug prices to help provide them with the information that will help them make the purchase decisions that will solidify the role of vital medicines in their healthcare regimen.

President should have known pharma was a snake when he picked it up

For the past three weeks, we have posted blogs wondering what the payback of the Obama Administration was to PhRMA in return for its 'support' of 'price cutting' for Medicare Part D Doughnut Hole prices, generating a claimed $80 billion savings.

We were among the first to suggest that the pattern of backroom dealing violated Candidate Obama's pledges of greater transparency and openness in government, and an end to the special relationship between industry groups and policy-makers. We noted with regret that the President had invited healthcare industry groups, including PhRMA, the trade association for the pharmaceutical industry, headed by Billy Tauzin, the former-Louisiana Congressman who not only engineered the restriction against price negotiation in Part D before resigning his elected post shortly afterward to accept a $2 million annual salary position as head of PhRMA. To some, including me, it appears that a case might be made that there could be a conflict between representing a Congressional district while leading a legislative effort that was going to reap billions of dollars in benefits for an industry that was soon going to offer you a $2 million salary. This was why we bemoaned the new found alliance of the Obama Administration with PhRMA.

We asked: What is the payback to the industry? It is an honored guest at The White House; it is praised by the President as he speaks to Seniors, praising pharma's largess in reducing their pain with the 'offer' to reduce the cost of medicines for those stuck in The Doughnut Hole; it negotiates with Senator Max Baucus, (D-MT), chair of the influential Senate Finance Committee (and the recipient of large contributions from the healthcare industry); it has the audacity to 'demand' that the White House 'clarify' its 'agreement' that the Administration will 'honor' its agreed-to commitment to not allow price negotiation--and it gets its way, as the White House quickly falls in line, even to the point of having Press Secretary Robert Gibbs flounder as he had to admit he really didn't know the details.

But then, in a complete flip-flop, the next day, a new stance emerges, largely due to opposition from House members such as Rep. Henry Waxman, chair of the influential House Energy and Commerce Committee, which included price negotiation in its markup of HR3200. Waxman put it bluntly--neither he nor the Committee were bound by the negotiations with the Administration or with Senator Baucus.

Apparently others had the same concerns at about the same time we started asking questions about the relationship of this Administration with the pharmaceutical industry. There is an increasing number of stories asking questions about details of the agreement.

This is a fortunate turn of events. During the campaign, Candidate Obama made two pledges regarding prescription medicines: (a) to lower prices for Medicare by removing the restriction on price negotiation and (b) to allow Americans to expand their freedom of choice by legislation that would allow personal importation of safe, affordable medicines from licensed, registered pharmacies in Tier One countries, those that have standards of safety and efficacy that meet or exceed those of the United States.

It is interesting to note that earlier this year--at about the time that the White House was starting its outreach with industry reps, including PhRMA, that seizures by the FDA of vital medicines from Tier One countries picked up. The question must be asked, was this another part of the deal being cut with PhRMA? It is well-known that in addition, the other monster under the bed for PhRMA is importation of medicines at affordable prices. Interestingly, these are the same medicines that the industry ships into this country at prices 60 to 70 percent higher.

After a concerted effort,including appeals directly to the President by publishers of leading websites for seniors, and news releases about the seizures, they declined.

The continued concern about seizures was the reason that we hailed the successful legislative maneuvering of Senator David Vitter (R-LA) for an amendment restricting such seizures, a stance that reaffirmed the banning of such seizures by Congress in 2006. Still, even the Senator has said that he is not confident that the Amendment will stick in conference, perhaps reflecting the feeling that many share that the reach of pharma is such that it can have its way.

And therein lies the moral of the dilemma that the President faces. Will legislation affecting the price and availability of vital medicines be conducted in the bright sunlight of openness and opportunity for total and equal participation by all? Or will we be subjected to the special interests of groups such as PhRMA?

If it should be the latter, we would like to remind our elected policy-makers of the old tale that so amply illustrates the consequences of bad decisions...the fable of the snake and the little girl:

A young girl was trudging along a mountain path, trying to reach her grandmother's house. It was bitter cold, and the wind cut like a knife. When she was within sight of her destination, she heard a rustle at her feet.

Looking down, she saw a snake. Before she could move, the snake spoke to her. He said, "I am about to die. It is too cold for me up here, and I am freezing. There is no food in these mountains, and I am starving. Please put me under your coat and take me with you."

"No," replied the girl. "I know your kind. You are a rattlesnake. If I pick you up, you will bite me, and your bite is poisonous.”

"No, no," said the snake. "If you help me, you will be my best friend. I will treat you differently."

The little girl sat down on a rock for a moment to rest and think things over. She looked at the beautiful markings on the snake and had to admit that it was the most beautiful snake she had ever seen.

Suddenly, she said, "I believe you. I will save you. All living things deserve to be treated with kindness."

The little girl reached over, put the snake gently under her coat and proceeded toward her grandmother's house.

Within a moment, she felt a sharp pain in her side. The snake had bitten her.

"How could you do this to me?" she cried. "You promised that you would not bite me, and I trusted you!"

"You knew what I was when you picked me up," hissed the snake as he slithered away.

The moral of the fable is that things are not always as the seem. PhRMA has not shed its skin. Americans pay the highest prices for prescription medicine in the world. The industry's predatory pricing has contributed to the costs that now are the biggest obstacle to necessary healthcare reform, and the 'savings' of the brokered arrangement carry a heavy price...we can only hope that it will not be a snakebite that creates a climate of an industry group dictating to the Administration and Congress, thereby throwing into question the need for and benefits of healthcare reform.

Where does the President Stand?

In the previous post, we note that the President during his comments to the AARP meeting, did not speak forcefully for price negotiation for prescription medicines in Part D, only indicating that further price reductions might be possible. On July 29 in Raleigh, he came out more forceful for price negotiation. Is a stronger statement on the right and value of personal importation of medicines next? And, what will be PhRMA's reaction to the following comment?

12:57 p.m. - A male doctor asks about the "high costs of prescription drugs in America." Obama says the U.S. spends 77 percent more for drugs than any other country. Says the prescription drug bill passed a few years back prohibited Medicare from negotiating with drug companies for lower prices, something that needs to be included in a new health care bill. Does laud the drug companies for offering lower costs as part on the ongoing negotiations in Congress.

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.”