At Business-standard.com, we have often asked readers to respond to debatable issues on a designated space on the website called Have Your Say. The product typically works as a Poll Q, except that instead of simply eliciting a boring 'Yes', 'No' or 'Can't say' type of response, it also allows the reader to put in his own opinion about why he feels the way he does about the issue.
A few years ago, we asked readers to tell us whether or not pharma MNCs should be allowed to charge whatever they pleased for life-saving drugs on whose research they claimed they had spent a bomb and then some. This particular Have Your Say was in response to a press release sent by a Delhi-based PR agency about how cutting drug prices could hinder the development of new drugs.
The pitch, based on a report commissioned a Swiss pharma company, was ostensibly against the price control that the government was considering implementing on critical medicines. One news report for instance, published in Business Standard, indicated that as many as 70 cancer drugs could come under the regulated regime.
I'm no expert on the pharma industry, and don't even know my ANDAs from my APIs, but anyone's uncle will tell you that the pharma industry, particularly the MNCs, thrive on honking about the humungous amount of dollars spent on R&D to bring out new drugs. It is an argument they have been using effectively to achieve two ends: justify the exhorbitant cost to the end-user of new and critical formulations and prevent the entry of cheaper competing products.
Take the case of pegylated interferon, for instance, which is used in the treatment of hepatitis C, and cost around Rs 16,000 a shot some years ago, give or take a few. Trouble is, if you had the more serious variant of this disease (Genotype 1), you would have ended up spending something Rs 7.68 lakh for 48 injections, with no guarantee that your liver would be cleared of the virus -- while some sites claim a success rate of up to 50 per cent in curing type 1, and up to 80 per cent for types 2 and 3, others peg the effectiveness of the drug at much less. It is another matter that you might have to deal with a series of frightening side effects that include, at the extreme, suicide ideation and execution. Worse, some sites claim the drug has, in some cases, badly damaged the very organ it was designed to protect.
Thankfully, the patent was shot down in November last year.
Question: Why should anyone fork out a fortune to pay for a remedy that may not work and plays havoc with the body and psychology?
Pegylated interferon is just one case. Another development in the pharma world that took place a few years ago is even more disturbing. How would you respond if you found out that the R&D for developing a therapy itself was a mega sham? And that the perpetrator wasn't some fly-by-night firm or third-party manufacturer, but belonged to the biggest pharma group in the world?
A researcher in the US accused drug maker Wyeth (owned by Pfizer), of paying $25,000 to ghostwriters to play up the benefits and downplay the harm of hormone replacement therapy in articles published in medical journals. According to the report, Wyeth was accused of mitigating concerns that hormone replacement therapy raises the risk of breast cancer, and supporting "the unfounded idea that the drugs offer some protection against heart disease".
Payoffs to ghostwriters or to doctors to push pharma products hardly qualify as R&D expenses, and while solid proof is hard to come by, are we to assume, with this example, that that is where money really goes? If that is the case, aren't we really paying for a pharma firm's fraudulent practice and not for R&D?
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The Supreme Court's decision to shoot down Novartis' patent application for Glivec comes as a shot in the arm for both, the Indian consumer (patient) and domestic pharma companies. Just imagine what could have happened, had the patent been granted. The patent office would be flooded with applications from pharma companies for new variants of critical drugs already in use, each of which would cite the Novartis case to push for protection. Needless to say, critical medication would become extremely expensive and out of reach of poor patients. It would also impact several small Indian players who have been providing cheap life saving medication to lesser developed nations.
Worse, all previous cases won by NGOs and public interest groups opposing patents would be reopened, with fresh verdicts favouring the MNC. And of course, what would stop Novartis from modifying Glivec once again, say five years down the line, and filing for a brand new patent once the existing one expires?
A few years ago, we asked readers to tell us whether or not pharma MNCs should be allowed to charge whatever they pleased for life-saving drugs on whose research they claimed they had spent a bomb and then some. This particular Have Your Say was in response to a press release sent by a Delhi-based PR agency about how cutting drug prices could hinder the development of new drugs.
The pitch, based on a report commissioned a Swiss pharma company, was ostensibly against the price control that the government was considering implementing on critical medicines. One news report for instance, published in Business Standard, indicated that as many as 70 cancer drugs could come under the regulated regime.
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The question assumes significance once again, given the shooting down of Novartis' patent application for its anti-cancer drug Glivec, which I think is a very positive development in the Indian health care horizon.
I'm no expert on the pharma industry, and don't even know my ANDAs from my APIs, but anyone's uncle will tell you that the pharma industry, particularly the MNCs, thrive on honking about the humungous amount of dollars spent on R&D to bring out new drugs. It is an argument they have been using effectively to achieve two ends: justify the exhorbitant cost to the end-user of new and critical formulations and prevent the entry of cheaper competing products.
Take the case of pegylated interferon, for instance, which is used in the treatment of hepatitis C, and cost around Rs 16,000 a shot some years ago, give or take a few. Trouble is, if you had the more serious variant of this disease (Genotype 1), you would have ended up spending something Rs 7.68 lakh for 48 injections, with no guarantee that your liver would be cleared of the virus -- while some sites claim a success rate of up to 50 per cent in curing type 1, and up to 80 per cent for types 2 and 3, others peg the effectiveness of the drug at much less. It is another matter that you might have to deal with a series of frightening side effects that include, at the extreme, suicide ideation and execution. Worse, some sites claim the drug has, in some cases, badly damaged the very organ it was designed to protect.
Thankfully, the patent was shot down in November last year.
Question: Why should anyone fork out a fortune to pay for a remedy that may not work and plays havoc with the body and psychology?
Pegylated interferon is just one case. Another development in the pharma world that took place a few years ago is even more disturbing. How would you respond if you found out that the R&D for developing a therapy itself was a mega sham? And that the perpetrator wasn't some fly-by-night firm or third-party manufacturer, but belonged to the biggest pharma group in the world?
A researcher in the US accused drug maker Wyeth (owned by Pfizer), of paying $25,000 to ghostwriters to play up the benefits and downplay the harm of hormone replacement therapy in articles published in medical journals. According to the report, Wyeth was accused of mitigating concerns that hormone replacement therapy raises the risk of breast cancer, and supporting "the unfounded idea that the drugs offer some protection against heart disease".
Payoffs to ghostwriters or to doctors to push pharma products hardly qualify as R&D expenses, and while solid proof is hard to come by, are we to assume, with this example, that that is where money really goes? If that is the case, aren't we really paying for a pharma firm's fraudulent practice and not for R&D?
* * *
The Supreme Court's decision to shoot down Novartis' patent application for Glivec comes as a shot in the arm for both, the Indian consumer (patient) and domestic pharma companies. Just imagine what could have happened, had the patent been granted. The patent office would be flooded with applications from pharma companies for new variants of critical drugs already in use, each of which would cite the Novartis case to push for protection. Needless to say, critical medication would become extremely expensive and out of reach of poor patients. It would also impact several small Indian players who have been providing cheap life saving medication to lesser developed nations.
Worse, all previous cases won by NGOs and public interest groups opposing patents would be reopened, with fresh verdicts favouring the MNC. And of course, what would stop Novartis from modifying Glivec once again, say five years down the line, and filing for a brand new patent once the existing one expires?