Patent Office Again Reviews Merck Drug

The U.S. Patent and Trademark Office has ordered a re-examination of a key patent for Merck & Co.'s blockbuster Singulair allergy and asthma drug, saying new questions have been raised about its "patentability."

The Patent Office decision comes as a U.S. judge is preparing a ruling in a February trial in which Teva Pharmaceutical Industries Ltd. challenged the Singulair patent in an effort to sell copycat versions before patent protection expires in 2012. Merck has defended the patent's validity in an effort to maintain market exclusivity through the patent's expiration.

The Patent Office re-examination represents a separate avenue that could clear the way for early generic competition for Singulair, which had $4.3 billion in world-wide sales last year, or 18% of Merck sales.

A spokesman for Merck, which is based in Whitehouse Station, N.J., said Thursday the Patent Office hasn't yet drawn any conclusions, and the drug maker believes its patent is valid. He added that the company doesn't expect the patent re-exam to have any bearing on the current litigation with Teva, and that Merck isn't sure how long the re-exam will take.

The Patent Office ordered the re-examination on May 20, saying "a substantial new question of patentability" has been raised by a New York firm, according to documents on the Patent Office's Web site.

In April, a firm called Article One Partners LLC filed a request with the Patent Office to re-examine the patent, citing information that wasn't brought to the attention of the patent examiner who reviewed Merck's initial application in the 1990s, including a paper by a Merck scientist.

Article One describes itself as an online community that encourages members to dig up previously undisclosed evidence related to the validity of patents. Article One pays members who find valuable evidence, and it sells evidence collections and analysis to clients.

Under patent law, a patent can be declared invalid if previous research -- known as "prior art" -- renders the claimed invention obvious to someone skilled in the art of drug development. Or, a patent can be declared unenforceable if the applicant engaged in inequitable conduct, such as by withholding information from the patent application reviewer.

Teva wasn't involved in the request for the Patent Office re-examination. In a letter to a U.S. judge in the court case Thursday, a Teva lawyer said the Patent Office's re-exam decision supports Teva's position in the trial.

Chinese drug regulators investigate adverse herbal drug reactions

XI'AN,- A drug producer in northwest China shut down temporarily while authorities investigated claims that its herbal injection caused chills and high fever in some patients, local drug regulators said Monday.

Wang Yongli, spokesman for the Food and Drug Administration of Shaanxi Province, said Xi'an Jiahui Pharmaceutical Co. Ltd. voluntarily closed so that an investigation could be conducted into Shenkang, an injection it produced to treat chronic renal failure.

After receiving injections, 23 patients at the Second Hospital of the Tianjin Medical University in north Tianjin City experienced chills and high fever, said Song Ligang, head of the Center for Adverse Drug Reaction Monitoring of Tianjin. All received prompt treatment and reported feeling better in four to six hours, said Song. The cases were all reported starting on May 11.

The Tianjin Institute for Drug Control said two batches of the drug tested positive in a pyrogen reaction test. Pyrogen reactions include chills, vomiting, high fever (up to 40 Celsius) and falling blood pressure. Severe reactions can be fatal.

Tianjin suspended the use of the drug on May 22. Cities and provinces including Beijing, Liaoning and Jilin also issued notices to hospitals, urging them to watch out for adverse reactions.

Initial investigation showed that the pharmaceutical company was not involved in illegal production, and the investigation would center on possible technical problems, said Wang.

Two problematic batches have already been recalled and now all the injections on the market would be recalled, said Wang.

"The risk is now under control," he said.

Since October, China has recalled herbal injections leading to adverse reactions including ciwujia, shuanghuanglian, yinzhihuang and qingkailing. A man was sentenced to eight years in jail for selling contaminated ciwujia injections that killed three people in southwestern Yunnan Province.

Two Local Men Charged With Stealing 85,000 Hydrocodone Tablets

LAWRENCEBURG -- Two Lawrence County men are accused of stealing more than 85,000 hydrocodone tablets from a pharmaceutical plant in Huntsville, Ala.

Michael Newton and Michael Barnett, who belonged to a flooring crew working at the plant, were arrested May 15 and are facing federal drug charges.

Security footage obtained by the Madison County, Ala., Sheriff's Department shows two men stealing tablets from the Qualitest Pharmaceutical plant.

Authorities say they found the stolen tablets at Barnett's and Newton's properties in Lawrence County.

AG Van Hollen: Requests $212 million in forfeitures from pharmaceutical company

MADISON -- Attorney General J. B. Van Hollen appeared today in Dane County Circuit Court to request forfeitures against Pharmacia totaling approximately $212 million, as well as an injunction requiring Pharmacia to report truthful prices. The request was based on findings by a jury in February that Pharmacia, a pharmaceutical manufacturer, caused 1.44 million violations of Wisconsin’s Medicaid fraud statute. 

“The jury determined that Pharmacia was committing fraud,” Van Hollen said. “This fraud caused taxpayers, the uninsured, and third-party payers to overpay for prescription drugs. Our system depends on truthful reporting. I am asking the Court to award these forfeitures to deter future fraud and to protect taxpayers and the health care system.” 

The dispositional hearing before the Honorable Richard Niess was the latest development in a case filed by the Wisconsin Department of Justice in 2004 against 36 pharmaceutical manufacturers. The court has not ruled on the matters addressed at the hearing and is not expected to today. 

Under Wisconsin law it is unlawful to make representations with the intent to sell pharmaceuticals when the representations are untrue, deceptive or misleading. Each defendant company allegedly identified average wholesale prices (“AWPs”) for their drugs which were provided to a pricing compendium relied on by the Medicaid program to reimburse pharmacists. 

Wisconsin law provides that a court may impose a forfeiture of not less than $100 and not more than $15,000 for each violation of the Medicaid fraud statute. Van Hollen proposed a sliding scale of forfeitures for the repeated violations that increased over time, reflecting a sanction for Pharmacia’s escalating unlawful behaviors. Additionally, he sought the injunction to ensure that the fraudulent reporting practices could not continue in the future. 

Three of the 36 manufacturers named in the lawsuit have settled with the state without trial, agreeing to pay over $3 million to resolve their claims. Trials against several other manufacturers are scheduled for next year.

Merck Wins Halt on California Vioxx Class-Action

Merck & Co. won’t face a class-action lawsuit filed by consumers seeking reimbursement for costs tied to the painkiller Vioxx, a California judge ruled, denying plaintiffs’ request to sue as a group.
Consumers who sued don’t meet legal requirements for a group claim, Los Angeles Superior Court Judge Victoria Chaney said in an April 30 ruling made public today. There appears to be no uniformity among the plaintiffs as to how much they paid for Vioxx, and their claims would require examination of each one’s medical history and prescription decisions, she said.
“Plaintiffs adduce no evidence indicating the inquiry can be conducted on a class-wide basis,” Chaney said in the ruling.
Merck, based in Whitehouse Station, New Jersey, agreed in 2007 to pay $4.85 billion to resolve lawsuits by people claiming Vioxx caused heart attacks and strokes. The consumer case sought to recover money for economic losses in California, not personal injuries. The ruling was mailed to lawyers for both sides and made public by Merck today.
“The court rightly agreed this was not an appropriate case to proceed as a class action,” Merck attorney Ted Mayer, of Hughes Hubbard & Reed in New York, said today in a statement.
Lawyers for the plaintiffs sought to recoup the cost of the drug for all consumers in California who purchased Vioxx from its debut in June 1999 to Oct. 1, 2004, the day after Merck announced its recall. The lawyers argued that class members wouldn’t have purchased Vioxx, or paid so much for it, had they known the cardiac risks, Chaney said in the ruling.
New Jersey Denial
“The court finds the amount of money lost as a result of defendant’s alleged wrongdoing is not subject to common proof,” Chaney said.
Chaney’s ruling follows a March decision by New Jersey Superior Court Judge Carol E. Higbee denying class certification to consumers who had sued in that state. Merck also won a ruling in 2007 from the New Jersey Supreme Court, which refused to certify a national class-action lawsuit over claims it misled health insurers about Vioxx’s safety.
Merck fell 42 cents, or 1.7 percent, to $24.79 at 1:26 p.m. in New York Stock Exchange composite trading. The shares have declined 19 percent this year.
The case is In Re Vioxx Consolidated Class Action, JCCP 4247, Superior Court of California, County of Los Angeles.

Pharmaceutical Industry Targeting NC Budget Savings

The pharmaceutical industry is mad. They are getting people to lobby their legislators. Emails are being churned out. Who knows what else is happening?

Why? Buried in North Carolina’s current budget proposal now being considered in the House is a move by Governor Beverly Perdue to save at least $20 million that the state currently spends on prescription drugs in its state health Medicaid program. The savings comes from implementation of a comprehensive preferred drug list. Long resisted by the pharmaceutical industry, this list would use independent research and evidence to encourage use only of drugs that work the best and cost the least. Paying millions for ineffective drugs is a luxury we can no longer afford in North Carolina.

Which drugs work the best and cost the least isn’t a mystery. Consumer Reports magazine maintains a comprehensive website (www.crbestbuydrugs.org) that reviews drugs for multiple different conditions, goes over the research on effectiveness, and looks at price – all to come up with the best drugs on the market. Anyone looking at the Consumer Reports publications quickly realizes that paying millions for prescription drugs that aren’t effective or are overpriced really makes little sense given how much we know about what drugs work and which ones don’t already.

The drug industry is in full cry against such commonsense suggestions however. We’ve posted a sample email that pharmaceutical industry representatives are using to bombard members of the General Assembly. You can read the whole thing, but this sentence pretty much sums it up:

SB 202 should protect patients by removing Preferred Drug List language from the bill…

Yes – it’s all about “protecting patients.” Of course it has nothing to do about protecting profits. Just imagine if Chrysler tried to prevent buyers from using Consumer Reports information when they purchased a car. Sorry Big Pharma, I think I’ll go with the Consumer Reports research instead. Let’s hope Governor Perdue’s (seconded by the NC Senate) suggestions survive in the House version of the budget. We can start saving money in health care we desperately need in this terrible budget year. Will common sense win out over the special interests?

Colorado chemo bill killed

A proposal requiring health insurers to cover the cost of expensive cancer-treatment pills as a medical benefit was killed by the House Health and Human Services Committee on a 7-4 vote, Monday.

Senate Bill 250, sponsored in the House by Rep. Dianne Primavera, D-Broomfield, was intended to make oral chemotherapy drugs more available to patients recovering from cancer.

Currently, the drugs are covered by most insurers as a pharmaceutical benefit and are considered too pricey for many cancer patients who pay a percentage of their prescription costs.

The bill was backed by patient advocates and large pharmaceutical companies who maintained that the pills let cancer survivors continue working because the treatments can be taken at home or at work rather than administered intravenously in a cancer center.

The pharmaceutical industry has pushed similar legislation in 22 states, including Oregon where the policy became law in 2007.

But opponents of the measure, including insurers, argued that oral treatments are extremely expensive and few of the medications are available in generic form.

They also point out the therapies aren’t necessarily more convenient since cancer survivors still have to make follow-up visits while they’re being treated for the disease.

According to estimates from Kaiser Permanente Colorado, the cost of treating 500 colon-rectal cancer patients with a full range of intravenous treatments and services would be $850,000. Meanwhile, the cost of treating the same group with oral chemotherapy drugs would be more than $9 million.

One Republican lawmaker in the Senate estimated the mandate would raise insurance premiums for Colorado families by as much as $147 a month.

The bill was approved by the Senate, the House Business Affairs and Labor Committee and the House Appropriations Committee, but met its fate on Monday during a hearing from the House Health and Human Services Committee.

Republicans in the minority party had opposed the legislation, but the measure was defeated when Democratic Reps. Sara Gagliardi, D-Arvada and Jim Riesberg, D-Greeley, the chair of the committee voted in opposition to the bill.

Masters Pharmaceutical fined by DEA

Masters Pharmaceutical Inc. will pay a $500,000 fine in a settlement with the Drug Enforcement Administration, which accused it of selling drugs to illegal Internet pharmacies.

The generic drug distributor, which did not admit to wrongdoing and cooperated with the investigation, will pay $350,000 by May 15; $100,000 in 2010; and $50,000 in 2011, according to a news release from Gregory Lockhart, U.S. attorney for the Southern District of Ohio.

The DEA claimed that Masters sold more than 4 million dosages of hydrocodone, phentermine and alprazolam to the Internet pharmacies between 2005 and 2008 and didn’t report the sales to the agency.

“By failing to report the suspicious orders for controlled substances that it received from rogue Internet pharmacies, Masters Pharmaceuticals contributed substantially to the explosive growth of prescription drug abuse in this country,” said Robert Corso, special agent in charge, Detroit Field Division of the DEA, in the release.

Masters, in a separate memorandum of agreement, said it had taken good-faith actions to detect and prevent diversions of controlled drugs.

Forest Park-based Masters was one of the finalists in the Business Courier’s “Fast 55” fastest-growing companies in 2008. The company had 2008 revenues of $100 million, up 18 percent over three years.

Government bans drug

Imphal, India: The State Government has banned sale and distribution of Manrovisc Opthalmic Solution; Batch No MCP-8116, expiry date August 2010, manufactured by M/s Health Biotech (P) Ltd, Sandholi, Baddi District, Solan HP under Mfg Lic No MB/05/158 .

With reference to an order of Central Drugs Standard Control Organisation (East Zone), Government of India, State Drugs Controller of Director of Health Services Manipur has issued an order today in this regard.

PennyStockChaser.com: King Pharmaceuticals, Inc. (NYSE: KG) Hot Stock on the Move!

NEW ORLEANS -- King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today presented the results from an oral abuse liability study of Acurox(R) (oxycodone HCl/niacin) Tablets, AP-ADF-111 (Study 111), at the American Society of Addiction Medicine's (ASAM) Medical-Scientific Conference. The results of Study 111 demonstrate that Acurox(R) Tablets are disliked among people with a history of opioid abuse compared to oxycodone HC1 tablets alone, when excess doses are swallowed. Dr. Donald R. Jasinski, Chief of the Center for Chemical Dependence of Johns Hopkins Bayview Medical Center, authored the study.

"The fact that people with a history of opioid abuse showed a disliking of the Acurox(R) Tablets in excessive doses is an indication that the product is an important step in the development of medicines that are designed to deter common methods of abuse, such as over ingestion, while effectively managing pain," said Dr. Jasinksi. "The ASAM Meeting provides a premier forum for King and Acura to share insights with addiction specialists and hear feedback that can lead to further advances in pain medication treatments."

King and Acura are jointly developing Acurox(R) Tablets whose New Drug Application has been granted a priority review classification by The U.S. Food and Drug Administration (FDA). The companies expect a response from the FDA by June 30, 2009.

Study 111 - A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Oxycodone HC1/Niacin Tablets (Acurox(R) Tablets) in Subjects with a History of Opioid Abuse

Acurox(R) Tablets contain a unique composition of oxycodone HCl, niacin, and essential functional inactive ingredients, and are intended to relieve moderate-to-severe pain while deterring common methods of prescription drug abuse including intentionally swallowing excess quantities of tablets, crushing and snorting tablets, and dissolving tablets for injection. Niacin is well tolerated at the recommended two-tablet dose, however, as doses are escalated, niacin induces increasingly unpleasant, dysphoric, yet temporary, effects.

To assess the effect of oxycodone HCl on the niacin-induced effects of Acurox(R), 30 subjects with a history of opioid abuse were administered 240 mg of niacin alone, Acurox(R) at four times the recommended 5mg/30mg tablet dose (40mg/240mg), and placebo, in randomized, crossover fashion (Sequence 1). To assess the abuse liability of Acurox(R) versus oxycodone HCl alone, the subjects were administered Acurox(R) at four times the recommended dose and oxycodone HCl 40mg alone in randomized, crossover fashion (Sequence 2).

The primary efficacy measure of abuse deterrence potential in Study 111 was determined using a 29-point visual analogue scale (Drug Rating Questionnaire-Subject) which assessed the subjects' like/dislike of a drug's effects. In Sequence 1, results demonstrated with statistical significance (p=0.03) that niacin 240mg was disliked compared to placebo, and oxycodone HCl 40mg had limited effect on niacin-induced disliking. In Sequence 2, it was demonstrated with clinically meaningful and statistically significant results (p=.033) that administration of excessive numbers of Acurox(R) Tablets equivalent to 40mg of oxycodone HCl (i.e., four times the intended 2 tablet dose) was aversive at 30 minutes compared to oxycodone HCl 40mg alone.

About Prescription Drug Abuse

The undertreatment of pain is a major public health issue complicated by abuse of prescription opioids. More than 75 million Americans suffer from pain, which is more than the number of people with diabetes, heart disease and cancer combined. While there are a number of effective prescription pain medications available, the increasing misuse, abuse and diversion of prescription pain medications - especially among young adults - is having a major impact on physicians' ability and/or willingness to treat pain and is impeding patient access to medicines and care. According to the National Institute on Drug Abuse, nearly 10 percent of high school seniors have abused Vicodin(R), a commonly used short acting opioid pain medicine. The increasing misuse, abuse and diversion of opioid pain medications have become widespread and pose a costly and significant public health issue in and of itself. In 2005, the estimated total cost associated with opioid abuse, including health care, justice, and work-related costs, totaled $9.5 billion. The pain relief medicines that Acura is developing with King are designed to address this problem.

FDA Warning: Pharmaceuticals in "Natural" Products

(AHC Newsletters Via Acquire Media NewsEdge) FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions.

Pharmacology Watch Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia ®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac ®, an SSRI), furosemide (Lasix ®, a loop diuretic), and even phenytoin (Dilantin ®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate.

In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra ®) and tadalafil (Cialis ®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales.

Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404).

PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel.

In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944).

Modafinil's abuse potential Modafinil (Provigil ®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154).

FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan ®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting.

A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid ®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex�.

The Politics of Tamiflu

A world wide shortage of antiviral drugs to fight Swine Flu H1N1 exists because of faulty decisions by world health authorities and socialist interference into private industry. Obama and the liberal left are complicit in poor vigilance and not protecting the American pharmaceutical industry which is strategically important to the health and security of the United States.

Every hour we are hearing about more cases of Swine Flu H1N1 infection occurring around the world. The virus has now proven itself to be easily transmissible between people but the question remains about how pathogenic (pathogenicity can be thought of as the potential to cause serious illness or death) the virus will be as it affects large populations. Public health measures such as limiting movement and isolating the affected will help but there is still a potential that 50% of the world’s population could be infected.

 

The virus might disappear as warmer weather sets in world-wide but since it will only have affected a small percentage of the population there will not be enough immunity in the population to prevent a recurring epidemic when the winter season begins again for the northern hemispheres including the United States. It is possible that an immunization to the virus may be developed by next winter but many say the chances of developing a successful vaccine in less than 8 months without compromising effectiveness or safety is small.

 

There are two drugs available to treat infection which could potentially save millions of lives. Tamiflu is an oral drug and Relenza is used as an inhalant. As I wrote earlier, the Bush administration had called for increasing the stockpile of Tamiflu, in preparation for a possible avian flu outbreak, to be increased from 50 million doses to 195 million doses in June 2008 when the flu pandemic response plan was created. The same plan that President Barack Obama praised in his 100 Day speech on August 29, 2009.

 

A few days ago the Obama administration revealed that the stockpile was never increased. Many on the left including the Huffington Post are accusing the “GOP” of “stripping” the flu preparedness initiative in the stimulus compromise legislation. They seem to forget that only two Republicans , Susan Collins and Olympia Snowe, voted for the package that stripped the funding originally proposed by President Bush. They have claimed that they did not intend that initiatives not be funded but that they wanted funding to be approved through other routes of legislation. Senator Arlen Specter who is now Democrat also voted for the measure but all the other Republicans in House and Senate did not approve the compromise. The removal of the funding that would have tripled the stockpile of Tamiflu was a Democratic plan voted in place by a Democratic majority.

 

The Huffington Post does not mention how they as well as Keith Olbermann, Chris Matthews and many others in the cast of the liberal news media spin group praised Specter, Collins, and Stowe for being “bipartisan” and thanked them for their working with the Democrats on the stimulus package.

 

If the Swine Flu H1NI virus does develop demonstrated severe pathogenicity then the current supply of Tamiflu according to a recent report in Nature may only be enough to supply 2% of the world’s population. Three factors have contributed to this potential shortage.

 

Since 2003 the world has been most concerned about the possibility of an avian flu rather than a swine flu epidemic. The development of Tamiflu was initially hailed as great success and many countries began to order it. At the same time there has been an international movement to limit patent protections for pharmaceuticals where countries are now claiming that they have the right to produce generic drugs for domestic consumption. Tamiflu become the poster child of the socialist movement against patents and private drug production.

 

Hoffman La Roche makes Tamiflu under license from the American developer Gilead. They have claimed that the process to make Tamiflu is long and complex and also depends upon some scarce ingredients. Under pressure from United Nations agencies and the threat that countries like Taiwan and India would produce their own Tamiflu if licensing agreements would not be signed guaranteeing a low price, decisions about production were difficult.

 

The United States has a strong history of promoting strong pharmaceutical patents but that may end with the Obama administration. Obama has proposed shortening pharmaceutical patents duration and putting patent approval for them up to public criticism and comment. One could easily imagine that private research companies will be dissuaded from developing new drugs if “activists” are demanding very short patent lengths. Conversely, Obama has also proposed a gold plated type of patent specification that will favor large companies over smaller start up companies which often are the main source of new innovations.

 

A key ingredient to make Tamiflu is shikimic acid. Up until very recently the source of this substance was the star anise plant. A variant of the plant is found in China which had relatively high concentrations of shikimic acid yet it takes many pounds of plant to get enough for one pill.

 

Along with the patent fight many generic drug companies and others have been looking for ways to supply this ingredient. Recently Hoffman La Roche signed an agreement with the French firm, Sanofi-Aventis to produce shikimic acid using e. coli bacteria. According to Nature, two thirds of Tamiflu production is from star anise and one third from the new process. In March of this year company spokesmen and academicians familiar with the process said that the production could be significantly increased but would take a year to maximize. American researchers are working on other promising sources of shikimic acid.

 

If only 2% of those infected with Swine flu H1N1 become seriously ill and half of the world becomes infected then the anticipated need for Tamiflu will be at least 30 billion capsules says Jeff Levi of the Trust of America’s Health. Many experts in infectious disease, the drug production process, and public health arena seem to agree that a drug shortage is inevitable if swine flu proves deadly.

 

Relenza requires an inhaler because the oral form is not well absorbed. There have been many legal fights between its inventors, Biota of Australia, and the licensed producer, pharmaceutical giant Glaxo which have hampered its development. Just as in the case of Tamiflu, Glaxo has been threatened by generic production and licensing from countries if their demands for low prices were not met.

 

Another contributing factor to the shortage of the antiviral drugs has been a controversy in public health circles as to the effectiveness of these drugs against avian flu. Up until the recent swine flu outbreak, world health officials had seemed to have forgotten about swine flu (the last outbreak occurred in the first Bush administration). Some researchers were reporting resistance developing in avian flu to Tamiflu especially. This prompted some health officials to restrict its distribution for fear of increasing resistance and also questioned the wisdom of stockpiling the drug if there was resistance.

 

Even if we get over this crisis, there will be more. Viruses will mutate to new forms that will become resistant to current drugs and immunizations. If the Obama plan to destroy the patent process for pharmaceuticals goes forward the mechanism for new drug development will be stopped cold. The protection of the American pharmaceutical industry is a strategic necessity. We need to have capability to not only develop but also produce drugs with readily available materials.

Pharmaceutical official must reveal assets

CINCINNATI, - Harriet Warshak of Berkeley Premium Nutraceuticals, which makes the drug Enzyte, must reveal all her assets or face jail time, a U.S. District judge says.

U.S. District Judge S. Arthur Spiegel said he was "disappointed" Warshak, who was convicted on fraud and money laundering charges last year, failed to report a $100,000 certificate of deposit to federal prosecutors, The Cincinnati Enquirer said Friday.

"Most alarming is the fact that defendant 'forgot' about a $100,000.00 certificate of deposit," Spiegel wrote in a court order. "The court is disappointed with both defendant's counsel and defendant."

Warshak, whose son Steve founded Berkeley Premium, insists she forget about the deposit funds despite asset records showing she used $10,000 of the funds to pay personal bills.

Spiegel said Warshak, 75, has 60 days to disclose all of her assets to avoid immediate jail time. The Enquirer said the U.S. District judge is allowing Warshak to remain free while appealing her two-year prison sentence from her 2008 conviction.

Steve Warshak was sentenced last August to 25 years in prison after he and other Berkeley employees were convicted of victimizing thousands of their customers by misrepresenting their products.

Use of unapproved drugs violates sound process

It's likely news to most Canadians that the wide-spread use of antibiotics in livestock includes unapproved drugs, but it's been on Health Canada's radar for at least seven years. And as the keeper of public health, the federal department needs to crack down on farmers who allow such drugs to enter the food chain.

This week's issue of the Canadian Medical Association Journal highlights the controversial usage.

The article claims it's the result of a loophole in federal law that allows meat producers to import about $100-million worth of medications to Canada each year.

It is done with little oversight, under the "own-use" provision, meant for individuals to import up to a 90-day supply of drugs for personal consumption.

Unfortunately, it has come to be widely interpreted by farmers as a way to import drugs for their animals.

The loophole was first identified in 2002 by an advisory committee which recommended Health Canada then stop the imports immediately.

The drugs include unapproved and untested antibiotics, often given to healthy animals to speed their growth or prevent disease outbreaks. Farmers say they need to do this to remain competitive, even though the use of these antibiotics as growth promoters was banned in Europe three years ago because of health concerns.

Medical experts here also fear increases in antibiotic resistant bacterial infections in humans, and the subsequent development of superbacteria.

When exposed to low doses of drugs over a period of time, animals develop a bacteria that's antibiotic resistant.

That creates a potential breeding ground for a superbacteria. Humans are at risk for picking up the drug-resistant bacteria, either by consuming undercooked meat, or by having contact with farm wastes, manure or other environmental contact.

As complicated as the issue is, it can be pared down to one thing: the rules are there for a reason and should be followed. Health Canada should act on the concerns of the medical community and close this loophole immediately. All drugs imported for use in food production should first meet registration and licence requirements.

The CMAJ article is in response to a task force report, quietly posted to Health Canada's website in December. The recommendations by the committee, dominated by representatives of the livestock industry, called for Health Canada to keep the loophole in place for another two years for further study of the product.

Study is appropriate, of course, but this looks like an industry bid to buy time.

First, deal with the use of unapproved drugs.

Second, test them.

Finally, if the drugs check out, they should by all means be reinstated.

The process is sound: it should be allowed to work.

Cut ties between Health Canada, drug companies, grieving MP urges

A federal Conservative MP whose 15-year-old daughter collapsed and died after taking a prescription medication will this week introduce a private member's motion calling for an arm's length drug safety agency.

Vanessa Young died in a hospital in Hamilton, Ont., in March 2000. Her father, Oakville MP Terence Young, believes a medication called Prepulsid or cisapride prescribed by their family doctor contributed to her death.

"She jumped up to go upstairs and fell down in front of me," Young recalled on CBC Radio's Metro Morning on Monday. "Her heart stopped dead."

At the hospital, doctors repeatedly asked the family who prescribed the drug. It was given to Vanessa to treat her mild form of bulimia, which sometimes caused her to feel bloated after eating.

As one of the doctors left the hospital the next day after Vanessa died, Young asked the doctor about the drug. The doctor's response — "Well, they dish it out like water" — led Young to start investigating adverse drug reactions.

Adverse reactions cause 10,000 deaths a year in Canadian hospitals when drugs are used as prescribed, Young said. Probably another 10,000 deaths occur outside of hospitals from prescribing errors and adverse reactions, he added, noting less than one per cent of reactions get reported.

China drug scams challenge pharmaceutical firms

BEIJING/HONG KONG - When Pang Jianli walked into a Beijing pharmacy to buy medicine for his flu-stricken son, he was greeted by an overwhelming display of boxes and bottles emblazoned with promises of miraculous cures.

"Unlike shopping in supermarkets, where I buy the brands I know and I know the brands I buy, buying drugs is different; the brands you know may not be what they claim to be," said the 38-year-old father.

China's poorly regulated medical market has spawned a new 'Wild West' for untested drugs offered by fly-by-night firms. The medical 'free-for-all' is reminiscent of the era of 'snake-oil salesmen' over a century ago in the United States.

From impotency treatments, to drugs that prevent hair loss, to medicines that cure chronic diseases, Chinese consumers are bombarded by adverts for a vast array of treatments making false or inflated promises.

Analysts say the murky business practices and misleading claims may actually help the prospects of foreign drug companies scrambling for a piece of the $110 billion medications market in China.

"Nowadays, Chinese people don't trust Chinese medications. They trust Western brands more as they have a better reputation," said Huang Jianshi, Assistant President of the Chinese Academy of Medical Sciences and Peking Union Medical College.

Foreign drug companies such as GlaxoSmithKline Plc and Pfizer Inc usually work directly with hospitals and doctors and rarely advertise, explained Du Jinsong, a pharmaceutical analyst with Credit Suisse in Hong Kong.

"Fake drug adverts have limited impact on foreign brands as foreign companies sell and market their products in a different way," he said.

Treatments being aggressively touted don't just promise to cure baldness or erase wrinkles, some also claim to cure chronic conditions such as hepatitis B, a disease that sometimes results in the need for a liver transplant, said Ewan So, president of the Society of Hospital Pharmacists of Hong Kong.

"If there was such a magic drug, we would have used it by now," he said. "A liver transplant costs between HK$500,000 to HK$600,000. Why go to all that trouble?"

China's State Food and Drug Administration (SFDA) counted 329,613 cases of the distribution of unlicensed drugs and medical products in 2007 and collected 746.17 million yuan (or $109 million) in fines.

But the fines have done little to deter the sale of untested drugs in a country where regulation is lacking and enforcement is lax. Analysts said it was hard to measure to what degree public mistrust of adverts have affected drug sales, which grew 26 percent to 752 billion yuan ($110 billion) last year in China.

"Like any other social issues in China, we now have adequate policy out there. The most crucial thing is how to effectively enforce the law," said Xu Jun, a pharmaceutical analyst at Orient Securities in Shanghai.