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Archive for June, 2010

Allison Bass’ most recent blog post should serve as inspiration to all , especially to those who think that nothing can be done:

Fighting for lower drug prices, or how to counteract Big Pharma’s lobbying

She gets right to the point with her analysis and recommendations:

Why? The reason is glaringly obvious: Congress won’t give the Department of Health and Human Services (HHS) the authority to negotiate lower drug prices because too many of its members are in bed with the industry. That’s why HHS was expressly prohibited from negotiating lower drug prices in the Medicare Part D legislation enacted during the Bush administration.

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It’s difficult for individual consumers to have much of a voice in the face of such well-oiled (forgive the pun) special interests. But it doesn’t hurt to try. So I will repeat what I told the Mount Holyoke crowd: Pick up the phone or write a letter/email to your Congressional representatives telling them that you want Congress to pass a law giving HHS the power to negotiate lower drug prices for Medicare and Medicaid (and while you’re at it, ask for a ban on direct to consumer advertising too).

Obviously this was a select crowd she was speaking to, but the message is clear and vital for us all. Time for everyone to become a broken record on the topic.

Allison is a journalist and medical writer, and author of the book  Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial.  Her blog focuses on “the serious flaws in our health care system and the need for reform.”


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This news just came in. So far, no  information to share on the status of cord blood stored for the NMDP registry  program.

Stem cell company sold for $100 at courthouse auction

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From Pharmalot, May 24, 2010:

Wyeth Marketing Targeted Blacks Illegally: Lawsuit

A pair of former hospital sales reps filed a whistleblower suit alleging Wyeth, which is now owned by Pfizer, illegally promoted its Rapamune kidney transplant drug for use with other organs and targeted African-Americans, even though this is a high-risk patient group, according to the product labeling ………..

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“Despite limited data on high-risk patients, Wyeth targeted transplant centers that catered primarily to African-American patients, typically in urban areas……………  Wyeth also instructed reps to use journal articles, including one published in Transplantion in July 2002 to off-label market Rapamune to African-Americans for combinations that were not approved by the FDA…………….

From Oncology NEWS International, May 13, 2010:

Global cost-sharing programs for pricey drugs fall short

Survey results indicate patient access schemes in the UK and the U.S. need refinement.

With the cost of cancer drugs increasing at a rate that is generally thought to be unsustainable, many countries are faced with the difficult question of how to ensure access to these drugs without breaking the financial resources of individuals and systems paying for them……….

From BBC News,  June 3, 2010

Cancer fund cash ‘will run out’

Making more cancer drugs available could cost far more than government estimates according to a BBC investigation.The government has allowed for a £200m cancer drug fund to pay for more cancer treatments from next year. But the cost could rise to £600m based on figures from drug manufacturers and the National Institute for Clinical Excellence (NICE).

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Health economist Professor Alan Maynard……………..said many of the cancer drugs were portrayed as wonder drugs when they only extend a patient’s life by three to four months.”The pharmaceutical companies’ PR has been first class.”

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These news items have as yet not received much attention, but highlight health issues of concern:

Asda to sell cancer drugs at cost price

Asda is to sell cancer drugs on a not-for-profit basis while thousands of NHS patients continue to be denied medicines that are deemed too expensive.

The supermarket giant called on other pharmacists to follow its lead and lower the price of all cancer drugs that are prescribed privately, to give patients access to drugs that are not always available on the NHS.

The move could save cancer patients thousands of pounds on the cost of treatments that may extend their lives by weeks, months or years, but which have been judged to be too expensive to be routinely available for free from the health service.

The move comes as the Government restated a pledge to make more expensive treatments available to NHS patients from April next year, with a £200million fund to pay for cancer drugs………..

What is not mentioned in the article is urgent need for price controls on medicines.  If the NHS  is going to be successful in implementing the new cancer drugs fund, it’s going to need to negotiate prices with the biopharmas.  No health system public or private, nor any insurer, employer, or individual has endless resources, although the drug companies typically act like purchasers do.  And for the most part , advocacy campaigns by patient and disease groups, no matter their location, seem to focus only on demands for drugs, not that  genuinely useful drugs be made available by being affordable.  With so many patient groups receiving industry funding, this is no surprise, but it certainly is not a sustainable position for resolving the access problems.  While the conflict-of-interest issue may have often garnered more attention in the UK than in the US,  it’s a growing, worldwide phenomenon.  And even in the UK, most ordinary folks simply cannot afford to pay out of pocket for drugs with 5- and 6- figure annual costs, nor can the NHS if it is to continue to fulfill its mission.

Asda is a large UK supermarket chain, part of the Walmart group.  Earlier this year, Asda pharmacies started selling specialty prescription drugs needed for IVF treatments, which likewise were not being covered by the NHS.

Also relevant to cancer treatment is a news item from the US:

Altamonte Springs stem cell company scheduled for sale at debtors auction

A judge has ordered Cryobanks International, an Altamonte Springs company that stores stem cells in super-cold freezers, to either repay a California businessman the $3.5 million he loaned it or be sold at a courthouse auction in two weeks.

Company President John R. Edwards, M.D., would not predict Wednesday what would happen to the company or who would wind up owning it.

Of the auction, he said, “I don’t know if anything can be done to stop it.”

But he stressed that the company’s stem cells would remain safe. From 5,000 to 10,000 units are currently housed in liquid-nitrogen freezers at the company’s Altamonte Springs office…………

The type of stem cells referred to are those from the umbilical cord blood of newborns, which now can be used  in the same way as bone marrow and peripheral blood stem cells, for transplantation  to replace the malfunctioning immune systems of patients with blood cancers and other diseases.  Most of the customers of Cryobanks International are private individuals who have paid to store the cord blood of their newborns as supposed “biological insurance” against many  future ills, often wooed by emotional marketing of an industry that is still unregulated in the US. Most medical groups worldwide, including the American Academy of Pediatrics, recommend against private cord blood banking, and stress the tremendous unmet need for donation to public banking programs to serve today’s patients. Because of the small volume of blood from the umbilical cord, most such transplants are done for children.

And therein lies the public health concern about the future of Cryobanks International.   In addition to its private clients, since late 2005 the company has been a network member of  BeThe Match (formerly called the National Marrow Donor Program or NMDP) , the federal contractee which operates the US national public cord blood registry. Currently it’s possible to donate cord blood only in a handful of states, and Cryobanks International is listed as offering a unique “mail-in” option for interested expectant parents living everywhere else. Information does not seem to be readily available about the federal subcontract, nor on how many cord blood units have been collected by Cryobanks International for the NMDP. (It’s also not clear why an exact count of  stored CBUs held by Cryobanks did not seem to be available for the news story.)  CI states it has a division in India as well, with an India-specific website listing multiple sites nationwide.

This is not the first time that questions and controversy  have swirled around  Cryobanks International. In 2003, CI was identified as the supplier of cord blood to an Atlanta regenerative medicine clinic raided and shut down by the FDA. Run by an osteopath named Mitchell  Ghen, the clinic offered unapproved treatments  to desperate patients with diseases like ALS. Ghen offered expensive therapies using cord blood stem cells, but it is not clear if these were actual blood stem cell transplants.  CI cut off supplies of cord blood units (CBUs) to Ghen, who then relocated his clinic to Belize ,offering the same treatments– source of the CBUs unknown–and generating the same concerns.

Subsequently, media outlets including the New York Times reported on other business  activities involving CI.  In 2005, CI stated it was negotiating a merger with a new cord blood company named Biostem, which previously ran parking lots, provided Internet services, and operated a small mining company in Washington state. According to the Times, Biostem was being promoted to potential investors through dubious advertising pitches for so-called penny stocks. According to SEC records, the merger was abandoned in 2007.

I’ll be writing more soon about the complex field of blood and marrow transplantation and other key policy issues.  In the meantime, the public needs solid information about what’s going on with Cryobanks International and the Be the Match program.  Stay tuned as I endeavor to learn more.

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