5 comments to “As U.S. Bids to Renew Relations With Havana, Heralded Cuban Diabetes Drug Remains Off-Limits”

  1. Byron Alsop

    Can someone please tell me which are the countries that
    have the Cuban made drug Herberprof?

    Byron Alsop email hidden; JavaScript is required

  2. Roy Lay

    “At last month’s meeting, the institute’s scientists reported that more than 170,000 patients in 23 countries have been successfully treated with the Cuban drug, with 71 percent showing improvement.
    “Their studies suggest, unlike other treatments using human growth factors, the potential for carcinogenesis from Heberprot is just about nil,” said Kelman Cohen.”
    I know a few people who would love to say screw the FDA, I want the drug and my foot. An old friend of mine just lost his, and another may lose one or both soon. This is criminal. We have screwed over Cuba for decades, and even our latest two Popes acknowledge this. Now we are screwing over Americans in the process. Cuba has always been happy to send medical teams to disasters around the world. Everyone there has health insurance, even though we’ve kept them from even getting spare parts for their vehicles and kept them in poverty. Sometimes I wonder if this country hasn’t become the world’s greatest problem. Even to most of it’s citizens.

  3. Barbara Dobriansky

    “we have only one FDA-approved pharmacologic to treat it, and that product has a black box warning,” the strongest warning label the agency requires”

    Are we making the presumption that a new drug would not have a similar warning. As has been previously commented, any “growth factor” would likely have similar side effects to other similar drugs. We only see the successes coming out of Cuba – not the failures.

  4. Irl Hirsch

    The other issue is for any drug to be marketed within the US, it has to pass rigorous FDA registration trials. While many over the years have been critical of the trials and the process, most of us feel comfortable that once a drug is approved, it has passed reasonable safety testing in addition to on-going surveillance for toxicity. Safety signals may show up in registration trials, but sometimes they do not. Diabetes drugs such as Rezulin and Avandia come to mind, as does Redux for obesity. All of these drugs were taken off the market once safety concerns were seen in the general population. Often major concerns turn out to be over-stated. Metformin is a good example of this.

    In the case of Heberprot, it is a growth factor, meaning what is the added risk (if any) of cancer and in the case of someone with diabetes, starting or worsening diabetic retinopathy which could potentially lead to blindness. To know this, likely thousands of people would need to be carefully studied. And just because there is a small risk of cancer or blindness, it doesn’t mean we shouldn’t have the drug available. Rather, the doctor and the patient can then decide the “risk-benefit” from a certain risk of a bad side effect countered against the benefit of saving the limb. These are very difficult decisions which can’t be answered without doing the proper studies. It may be for example, if no retinopathy is present there is no risk to the eyes, whereas if there is already advanced retinopathy the drug shouldn’t be used, meaning every patient needs a dilated eye exam before starting the drug.
    So although this is all so frustrating, the safety issues seem to trump everything.

  5. Doug Baldwin

    Interesting article. But it arouses curiosity about international drug patents that is not addressed. What exactly makes this a “Cuban” medicine? Did they patent it, even though it originally had an American start per the article? If so, and if such patents have international recognition, why can’t another drug company do a deal to test, produce and market this drug in the USA? Does the embargo not only cover physical goods, but the origination of intellectual property? So, if a Cuban company was to benefit from a presumed international patent it held, by licensing a patent agreement with a European company, and that European company then made a manufacture and distribution deal with a US company, and the US company then began US testing to get FDA approval, is that embargoed because a Cuban company benefits down the line from this? In that case, does that mean we also embargo ideas (books, music) from Cuban artists, even if those artists receive royalties? I don’t think so. Is that an exemption that medical information ideas don’t have?

    In other words, this story opens up the larger topic of the Cuban embargo and intellectual and artistic idea embargos, (which have additional pertinence due to Muslim insistence that they can “embargo” the Prophet’s image from appearing in any country) and what an embargo is and what it means. The Cuban Embargo has been going on so long everyone has forgotten or lost interest in the details. Why exactly can’t the intellectual property of a Cuban person or company cross into the USA if similar artistic property can? If Ry Cooder can get around it, can’t some group of doctors?

    Doug Baldwin

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