News about Prescription Medicines

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Wednesday, April 22, 2015

Why did the FDA make a statement about Health Canada that gives False Impression of Safety, Efficacy

The publisher of a leading informational website on the high cost of prescription medicines in the U.S. says Congressional supporters of personal importation of safe, affordable prescription medicines should demand that the U.S. Food and Drug Administration explain why it says that it is ‘unable’ to ‘ensure’ the safety and efficacy of prescription medicines approved by Health Canada for sale in Canada, if those medicines are purchased by U.S. citizens.

Daniel Hines, publisher of RxforAmericanHealth and TodaysSeniorsNetwork says that on its website, the FDA notes:  “... if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

“This statement is a reflection of the flawed reasoning and overreach of the FDA,” says. Hines.  He points out that Health Canada is internationally recognized for its proven record of professionalism and safety in its oversight of the Canadian health system.

“As a matter of fact, Health Canada and the FDA have indeed independently reviewed and approved many of the same brands of medicines. The only distinction is that the labeling of the Canadian medicine is different from that of the same medicine sold in the U.S,” Hines explains.

Hines points out that by suggesting that Health Canada does not have the expertise to determine the safety and efficacy of a medicine, the FDA has moved from being a regulatory agency to taking an advocacy stance that flies in the face of the facts, and undertaken a stance that is directly contrary to legislation introduced in the U.S.Congress.

 He points to S. 122, a bi-partisan bill introduced by Senators Amy Klobuchar (D-MN) and John McCain (R-AZ) calling specifically for facilitating personal importation of medicines from Canada that are approved by Canadian Provincial authorities, which are subject to the oversight of Health Canada.

“This is a recognition of the safety of medicines approved by Health Canada, and by extension, the regulatory agencies of other Tier One countries whose standards of safety and efficacy meet or exceed those of the U.S.,” Hines says.

“One can only hope that Senators Klobuchar and McCain demand that the FDA retract this disingenuous statement about Health Canada, an agency of the highest repute, and ensure that the FDA not make such statements about legislation awaiting consideration of the United States Congress in the future ,” he says.

He concludes that the stance of the FDA should also be questioned as to its relationship with Pharma since the FDA stance reflects the claims of Pharma.

He also urges that Congress be alert to what supporters of personal importation fear will be a misguided application of Section 708 of the Food and Drug Administration Safety and Innovation Act that runs contrary to Congressional intent.

“The soon-to-be-announced rules for administration of Section 708 which authorizes the seizure and destruction of imported prescription medicines deemed to be counterfeit, unsafe, or ‘misbranded’, takes on special importance since if medicines approved by such an internationally respected authority as Health Canada are deemed to be ‘illegal’ or ‘unsafe’, the FDA will, almost certainly rule the same is true of other countries.

“This will lead to the spectacle of the FDA-- an agency ostensibly designed to protect and promote the health and well-being of Americans --doing just the opposite by destroying valid personally imported vital medications which, at prices of as much as 60 percent more in the U.S., are unavailable because they are unaffordable.

“The only beneficiary of such action will be Pharma, as the FDA endangers one of the few avenues of relief for Americans from the industry’s predatory pricing practices.”


Monday, April 20, 2015

‘Curiouser and Curiouser!’ The Alice in Wonderland World of the FDA



Alice in Wonderland, recognized as a‘Children’s Classic, also is a reflection of our own Wonderland populated by strange creatures whom, as one sees and hears more of them, we discover that, as Alice said, things get ‘Curiouser and Curiouser.’

 It’s called The Beltway, a reference to the seat of our Federal government (although several agencies have headquarters outside the ‘physical boundaries’ of The Beltway, it is the ‘Source’ or Mother head from which all our laws and regulations flow).

It is comprised of both elected and unelected persons who make decisions that affect our everyday lives, our health and well-being, and our prosperity...and not always for the best. 

That’s because, unfortunately, the things that they do too often reflect special interests, are based on self-contradictory stances, and exhibit complete disregard for facts that disrupt their Wonderland.

The most notable example of this denial of facts is evidenced by the Food and Drug Administration (FDA) decisions affecting the right—and the need—of Americans to make personal, responsible decisions to determine that safe and affordable brand-name medicines are indeed available from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the FDA, and are therefore safe sources for them to use to purchase their medications.

The FDA reflects Alice’s thoughts even before she descends into Wonderland.  Consider this telling quote she makes:  “If I had a world of my own, everything would be nonsense. Nothing would be what it is, because everything would be what it isn't. And contrary wise, what is, it wouldn't be. And what it wouldn't be, it would. You see?”

Yes, Alice and FDA we see.  Both of you believe you have a world of your own and it is subject to the bending of your will, even though the FDA was ostensibly designed to protect the health and well-being of American citizens, ensuring among other things that the prescription medicines made available to Americans are indeed safe and effective.

That is why the ‘Long Title’ of The Prescription and Drug Marketing Act of 1987 is: An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other purposes.

Although, the ‘reimportation’ mention is specific to restrictions upon reimporting medicines produced in the US, marketed outside the Country and then brought back into the US, i.e., ‘reimportation’, the FDA, in collusion with the special interests of Pharma  shapes its and our world with that ‘reimportation’ of prescription medicines somehow doesn’t mean what it means.

To come to such a conclusion, the FDA and Pharma say that the law doesn’t mean what it means.


Significantly, all the Lipitor produced by Pfizer for sale in the US is manufactured in Ireland for sale in the US and elsewhere.  That means it is imported into this country, whether by Pfizer or by individuals. 

Pfizer, as the manufacturer of Lipitor has the right, of course, to sell the medicines it produces, but in the absence of any restriction upon the right of individuals to personally import their medicines, then it is self-evident that Americans do indeed have the right to personally import their Lipitor and other prescription medicines.

In yet another example of Wonderland-speak, the FDA refers to seized personally imported Lipitor prescriptions as a ‘new drug’ or a drug not approved by the FDA, although it clearly is a valid medicine ordered by an individual with a doctor’s prescription.  So, says the FDA,  it is not what it is.

A further reading of The Prescription and Drug Marketing Act of 1987 makes it abundantly clear that the law’s intent is to ban ‘certain’ resales of reimported medicines “by hospitals and other health care facilities...” and there is no intent to restrict Americans from purchasing their medicines via personal importation, except for the FDA creating its own world where nothing is what it seems.

But perhaps the best example of this bizarre world is on the FDA’s own web page as it answers the question: Is it legal to import prescription medicines?

The FDA response:  “In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

Let’s take this point-by-point:

FDA Statement: In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States.

Common Sense Response:  The FDA says drugs sold in other countries to their citizens ‘often’ have not been approved by the FDA.  The use of the term ‘often’ indicates that there are some drugs that the FDA has approved.  The FDA should let us know which of those medicines have been approved...or should the ‘often’ term be ‘never’?  (The answer is ‘never’.)

FDA Statement: “For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

Common Sense Response:  This is the winner of the Wonderland double-talk award.  Senator Bernie Sanders (I-VT) has asked opponents of personal importation: “Where are all the Dead Canadians”.  It is ludicrous of the FDA to say that a medicine approved by Health Canada is inferior to that of the FDA.  Also, the FDA talks about  challenges in ‘ensuring’ the safety of the drug, even though it is the same medicine as sold in the US. 

This statement is also a reflection of the abuse and overreach of the FDA.  Congress has repeatedly supported personal importation in favorable votes only to be stymied by unprecedented ‘certification’ requirements by the Secretary of Health and Human Services.  Now, S. 122, a bi-partisan bill introduced by Senators Amy Klobuchar (D-MN) and John McCain (R-AZ) calls specifically for facilitating personal importation of medicines from Canada that are approved by Health Canada.

By suggesting that Health Canada dos not have the expertise to determine the safety and efficacy of a medicine, the FDA has moved from being a regulatory agency to an advocacy stance that flies in the face of the facts, and undertaken a legislative initiative that is outside its legal boundaries as a department of the executive branch.

One can only hope that Senators Klobuchar and McCain will demand that the FDA remove this incorrect statement about Health Canada, an agency of the highest repute.


At least for Canadians?  Really, is there a genetic distinction between Americans and Canadians that makes a prescription safe for Canadians, but somehow unsafe for Americans?  Not hardly. But then, in this world of outlandish claims, everything is nonsense. Nothing is what it is, because everything would be what it isn't. And contrary wise, what is, it wouldn't be. And what it wouldn't be, it would.

“You see?”

It is time for Congress to step up and end this Alice in Wonderland scenario and to direct the FDA to cease attempts to increase its intended limited authority, and to work on behalf of the millions of Americans who are being denied their access to safe, affordable medicines because of illogical and contradictory actions that usurp legislative oversight and direction of the agency. Otherwise, things will get ‘Curiouser and Curiouser’!

Friday, April 10, 2015

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Tuesday, March 31, 2015

Enough is Enough: Time to refute Pharma's 'claims', and for Congress to Act on Personal Importation of Safe, Affordable Medicines

After working for nearly 15 years on behalf of support of the right of Americans to purchase safe, affordable prescription brand name medicines from licensed registered pharmacies in Tier One countries, I am not usually shocked by the tactics of Pharma and its supporters to discredit the safety and efficacy of personal importation.

But, I did suffer what the old Baptist Preacher once referred to as ‘Righteous Indignation’  when I read a blog in The Hill by Sally C. Pipes with her blog “Drug importation is a dangerous idea that won’t die”

Why?  It  was one of the worst examples I have witnessed of a complete disregard for facts, and insulting the intelligence of the American public.

Her claims about safety of personal importation and the risks to Americans were not supported except by the old canards of Pharma. 

And, the rank misstatements about the costs of medications in this country were ludicrous...she said, believe it or not, prescription drug costs are not major drivers of health care costs nor are they increasing, completely ignoring that they are indeed exceeding the rate of inflation and spiking to costs that threaten to decimate health care systems around the country.

But then I did some googling...and discovered that Ms. Pipes, who is president, CEO and Taube Fellow in Health Care studies at the Pacific Research Insititute is just doesn’t get it, likely the residue of exposure to the outlandish claims of Mayor Guiliani, for whom she served as one of his four health care advisors in his bid for the Republican nomination for president in 2008.  While he will also be remembered as America’s Mayor of his efforts after 9-11, he also had some fatal flaws, including believing personal importation to be a terrorist threat.  While Ms. Pipes does not go that far, her claims of personal importation being a ‘dangerous threat’ to the health and well-being of Americans is up there with Mayor Guiliani’s claims of terrorism.  There is no there there.

With that in mind, I began to look at the Blog as an opportunity for a point-by-point rebuttal of her claims.  The ‘dialogue’ follows, with her comments followed by a response to set the record straight:

·         The Claim:  “A federal judge just struck down a program in Maine allowing state residents to import prescription drugs from foreign countries. The reason: it’s against federal law...”

The facts:  Either a total misreading of the ruling or a blatant misstatement of facts. The ruling had nothing to do with the legality of personal importation.  What the Judge dealt with was the question of Federal Supremacy. She decided that while the state lacked the authority to act, it is clearly within the right and intent of Congress to address legislation to allow personal importation if it chooses to do so. She (the judge) also noted that Congress has acted in such a manner many times with passage of bills in support of personal importation that were not fully implemented because of failure of ‘certification’ actions by the executive branch. Ms. Pipes  also fails to note that existing law allows the importation of medical devices and medicines that are ‘unavailable’ in the US...simply put, a medicine that is unaffordable is unavailable. Significantly, the FDA has selectively allowed 90-day quantities of personally imported medicines for years.

·         The Claim:  “And more immediately, foreign drugs pose a risk to Americans' health...”

The Facts:  A complete falsehood. The judge’s decision did not include such a statement. This is simply the Mantra of Pharma. It also exhibits Ms. Pipes’ long-standing bias of adopting outlandish claims of Pharma.  Virtually all prescription medicines sold in the U.S. are manufactured outside the U.S.  We can all agree that the scourge of bogus websites claiming to be pharmacies and dispensing counterfeit medicines without a prescription form a doctor is a potential health threat. However, there is no record of a single death or health risk to Americans as a result of personally importing their medicines prescribed by their physician and ordered from licensed, registered pharmacies.

·         The Claim:  “For this reason nearly every Congress since the Clinton administration has decided against legalizing drug importation...”

The Facts:  Ms. Pipes would be well-advised to become more conversant or at least be factual about American political history regarding personal importation.  There have been several instances of staunch bi-partisan support of personal importation in Congress, from such Congressional leaders as then-Congressman Rahm Emanuel (D-Chicago) who later became Chief of Staff for President Obama before becoming Mayor of Chicago; Senators Olympia Snowe (R-ME) and Byron Dorgan (D-ND) who brought forth legislation that was approved on preliminary votes only to be rendered ineffective by ‘certification’ requirements upon the Secretary of Health and Human Services that were unprecedented and supported by Pharma interests in Congress.  But, perhaps most significantly, the FDA has, as noted above, espoused a policy of not seeking prosecution of individuals personally importing their medicines.

·         The Claim: “But some in Congress are pushing to open up America's medicine cabinets to foreign drugs. Indeed, Sens. Amy Klobuchar (D-Minn.) and John McCain (R-Ariz.) have repeatedly introduced legislation to allow the importation of drugs. When Congress debates the nation's budget later this month, Klobuchar and McCain could attach a drug-importation amendment. If they succeed, it will come at a huge cost to American patients...”

The Facts:  Ms. Pipes not only misrepresents the Judge’s decision in the Maine suit, but in her next breath, she would deny American elected-officials the right to act in the very manner prescribed by the Judge—i.e., Congressional action. Since her stance is un-defendable she resorts to a vague reference of an undefinable ‘cost’ to Americans.  Actually, more than 55 million Americas today are denied the health benefits of access to safe, affordable prescription medicines simply because of paying the highest prices for prescription drug costs in the industrialized world.  Without an ability to follow a regimen of vital prescribed medicines, they incur real costs detrimental to their financial and health well-being. This will adversely affect their personal health later in life, likely contributing to diseases and conditions that are inherently drivers of increased health care costs that  could have been averted if access to vital medicines had been available previously.  Interestingly, Ms. Pipes and her organization claim to be supportive of personal responsibility and individual freedom in the marketplace.  Is she aware that former Congressman Ron Paul supported personal importation with a bill that said , ‘just do it.’ 

·         The Claim:  “On the face of it, allowing Americans to purchase prescription drugs from abroad is an appealing idea. Thanks to price controls, drugs in my home country of Canada, if they are even available on a formulary, often carry a lower price tag than their American counterparts. In the UK, meanwhile, per capita prescription drug spending is about half what it is in the United States...”

The Facts:  As Senator Berne Sanders said, ‘show me the dead Canadians...’ The comment about if a drug is ‘even available’ on a formulary is pandering by Ms. Pipes to those Americans who don’t truly understand the breadth of the Canadian system and fear that it somehow might be a threat to the U.S.  Ms. Pipes makes an almost painful concession that prescription medicines prices are indeed lower in Canada than the U.S., and the same is true of the U.K.  What she fails to note is that this is true in virtually all the other industrialized Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S., all the while offering prices of as much as 60 to 80 percent less.  And, even for those in the U.S.  who can ‘afford’ their medications, here’s a report on how much they ‘overpay’:  $1,268 for Overpriced Medications
According to Dean Baker, "government granted patent monopolies raise the price of prescription drugs by close to $270 billion a year compared to the free market price." This represents an astonishing annual cost of over $2,000 to an average American family.  OECD figures on pharmaceutical expenditures reveal that Americans spend almost twice the OECD average on drugs, an additional $460 per capita. This translates to $1,268 per household.

·         The Claim:  “While importing prescription drugs might save American patients money in the short-term, it comes with enormous long-term costs. For one, it cuts off the research funding that drug laboratories need to develop the next generation of treatments. According to researchers at Tufts, it takes drug companies roughly $2.5 billion over the course of a decade to bring just one new medicine to market...
·         “...One of the reasons countries like Canada can impose price controls on their drugs is that much of that multi-billion-dollar investment is made back in the American market. A wave of drug importation would make pharmaceutical investment far less attractive, choking off funding for the researchers who work to develop the next generation of treatments for diseases like cancer and Alzheimer's...”

The Facts:  The implication is that Canada is able to charge less because Americans pay more and this is necessary for R&D.  This is the oft-disproven canard of Pharma and is without any basis in fact, especially since U.S.taxpayers subsidize 56 percent of the R&D, which is done at the National Institute of Health (NIH). 

Take a look at the R&D expenditures of Pharma as compared to the ‘marketing’ directly to consumers, which is forbidden in Canada.

  

The drug industry’s claim that R&D costs as much as $250 million for each new drug (including failures) is highly misleading. The first thing pharmaceutical companies say when they answer questions about the retail cost of drugs is that prescription drugs cost a lot of money to get approved by the FDA. That stems from the millions of dollars that get spent developing the drugs for which they get a virtual monopoly.

That is why Pharma spokespersons can make such outrageous claims such as “The drug companies have to put a price on a medicine that reflects the cost of developing them,”  as John Castellani, the CEO of PhRMA told 60 Minutes. Castellani blames insurance companies for making drugs “artificially expensive” for patients.

In fact, the more disturbing truth is that companies charge what they want in the U.S., and it’s what many have described as “a profiteering paradise for them.”

PhRMA, the industry lobbying group, released a 2013 report showing that drug companies spent an estimated $48.5 billion on R&D in 2012. The most current figures they have (from the early 2000′s) show the cost of developing one drug is about $1.2 billion.  However, University of Medicine and Dentistry of New Jersey Health professor and policy expert Donald W. Light challenged the notion that high drug prices are simply the cost of doing business. He said the actual cost is less than $60 million once all the padding is taken off since the estimate is based on only the most expensive drugs with extensive clinical trials.

We agree with the observation of industry observers that, as noted as long ago as a 2001 report of Public Citizen, it defies logic that R&D investments are highly risky if the industry is consistently so profitable and returns on investments are so high.

Drug industry R&D is made less risky by the fact that only about 22 percent of the new drugs brought to market in the last two decades were innovative drugs that represented important therapeutic gains over existing drugs. Most were "me-too" drugs, which often replicate existing successful drugs.

·         The Claim:  “This is especially true when you consider that prescription drugs aren't a major driver of rising health expenditures. Between 2008 and 2012, prescription drugs accounted for a mere 5 percent of the growth in U.S. health spending. Today, retail prescription drugs account for only about 10 percent of overall U.S. health spending -- a statistic that isn't expected to change in the next decade...”
·         The Claim:  “None of these concerns has dissuaded Klobuchar, who, together with McCain, has led the fight to legalize drug importation. Twice last year, the two lawmakers introduced legislation to let foreign medicines flow freely into the country...With this latest attempt, Klobuchar and her allies may try to win over Senate Republicans by portraying drug importation as a free-trade issue. But importing price controls from foreign countries -- at the expense of both medical innovation and patient safety -- bears little resemblance to free trade...”
The Facts:  Saving the best for last.  One of my early experiences with the way Pharma works is when I was able to arrange a luncheon for then-Governor Tim Pawlenty (R-MN) after the Pfizer board meeting in St. Louis with Seniors who personally imported their medicines .  The Governor was livid when he came into the luncheon, primarily over comments by the then-Chairman of Pfizer Hank McKinnell in response to the Governor’s call for an election-year ‘Prairie Fire’ to support personal impoartation.  Chairman McKinnell said that personal importation really was like a Prairie Fire and that Pfizer was used to such things happening about every three or four years, before they burn out as an issue.  But, most surprisingly, McKinnell suggest that personal importation was really—are you ready Ms. Pipes—a free trade issue. The point is that just as it charges what the traffic will bear, Pharma also says what pleases it as any given time.

So it is not surprising that Ms. Pipes should dust off the old tired defenses as she recites the Pharma litany.  She mistakenly believes, as did the Pfizer Chairman, that the American people are not able to adequately make very real personal health decisions based on  intelligent considerations...and that the Prairie Fire will go out again.  It is time for Congress to prove her and others wrong.